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A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV) (CMV)

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ClinicalTrials.gov Identifier: NCT01376778
Recruitment Status : Completed
First Posted : June 20, 2011
Last Update Posted : September 22, 2021
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
The George Washington University Biostatistics Center

Tracking Information
First Submitted Date  ICMJE June 15, 2011
First Posted Date  ICMJE June 20, 2011
Last Update Posted Date September 22, 2021
Study Start Date  ICMJE April 2012
Actual Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2020)
Composite Outcome [ Time Frame: 3 weeks of life ]
The primary outcome is a binary outcome defined by the occurrence or non-occurrence of any of the following vs. none of the following: fetal loss (spontaneous or termination), confirmed fetal CMV infection from amniocentesis, neonatal death before assessment of CMV infection can be made, or neonatal congenital CMV infection. Neonatal congenital CMV infection is diagnosed by urine or saliva collected by 3 weeks of age that is positive for CMV by culture (the intent will be to obtain in the first two days of life). In the event that Polymerase Chain Reaction (PCR) is positive but culture is negative, a repeat culture must be positive by 3 weeks of age.
Original Primary Outcome Measures  ICMJE
 (submitted: June 16, 2011)
Composite Outcome [ Time Frame: 3 weeks of life ]
The primary outcome is defined as fetal loss (spontaneous or termination), confirmed fetal CMV infection from amniocentesis, neonatal death before assessment of CMV infection can be made, or neonatal congenital CMV infection. Neonatal congenital CMV infection is diagnosed by urine or saliva collected by 3 weeks of age that is positive for CMV by culture (the intent will be to obtain in the first two days of life). In the event that PCR is positive but culture is negative, a repeat culture must be positive by 3 weeks of age.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2020)
  • Gestational hypertension [ Time Frame: from approximately 20 weeks of gestation through delivery (maximum 42 weeks gestation) ]
    Gestational hypertension is a binary outcome defined by occurrence or non-occurrence of gestational hypertension. Gestational hypertension is a new onset hypertension during pregnancy
  • Preeclampsia [ Time Frame: approximately 20 weeks of gestation through 6 weeks postpartum ]
    Preeclampsia is a binary outcome defined by occurrence or non-occurrence of preeclampsia defined as a patient exhibiting new or worsening hypertension with proteinuria
  • Placental abruption [ Time Frame: From 16 weeks of gestation through delivery (maximum 42 weeks gestation) ]
    Placental abruption is a binary outcome defined by occurrence or non-occurrence of placental abruption, defined as bleeding and contraction pain
  • Gestational age at delivery [ Time Frame: Delivery ]
    Gestational age at delivery in weeks and days
  • Gestational age at delivery before 37 weeks [ Time Frame: Delivery before 37 weeks gestation ]
    Gestational age before 37 weeks gestation is a binary outcome meaning occurrence or non-occurrence of delivery before 37 weeks gestation
  • Gestational age at delivery before 34 weeks, 0 days [ Time Frame: Delivery before 34 weeks gestation ]
    Gestational age before 34 weeks, 0 days gestation is a binary outcome meaning occurrence or non-occurrence of delivery before 34 weeks gestation
  • Side effects [ Time Frame: From randomization (10-27 weeks gestation) through delivery (maximum 42 weeks gestation) ]
    Occurrence or non-occurrence of a designated side effect of medication
  • Treatment emergent severe adverse events [ Time Frame: From randomization (10-27 weeks gestation) through delivery (maximum 42 weeks gestation) ]
    Treatment emergent serious adverse events is a composite binary outcome repeated over time (with the exception of maternal death) and is the occurrence of any one of the following: • Maternal death during the study and while pregnant from any cause related to pregnancy, but not from accidental or incidental causes • Anaphylaxis defined as an acute syndrome occurring within minutes to hours of administration of the study drug and consisting of one or more of the following sets of symptoms: - Angioedema (swelling) of the lips, tongue, uvula and/or throat - Generalized hives, flushing or pruritus accompanied by clinically significant hypotension (usually with tachycardia) - Objective signs of dyspnea such as stridor and/or wheezing • Pulmonary embolism confirmed by spiral CT (or strong suspicion on VQ scan if spiral CT not done) • Deep vein thrombosis confirmed by venogram
  • Maternal viral load [ Time Frame: From approximately 14-27 weeks gestation through delivery (maximum 42 weeks gestation) ]
    Viral load following the last infusion where viral load is defined as the amount of cytomegalovirus in copies/mL
  • Fetal mortality [ Time Frame: From randomization (10-27 weeks gestation) through delivery (maximum 42 weeks gestation) ]
    Fetal death
  • Neonatal mortality [ Time Frame: 0 days to 120 days of life ]
    Death of a neonate that was born alive
  • Primary outcome excluding terminations [ Time Frame: randomization to 3 weeks postpartum ]
    Occurrence of the primary outcome including spontaneous fetal death but not termination
  • Neonatal Head circumference [ Time Frame: 72 hours postpartum ]
    Neonatal head circumference measured within 72 hours of birth
  • Birth weight [ Time Frame: Delivery ]
    Birth weight as recorded in the medical record
  • Growth restriction [ Time Frame: Delivery ]
    Growth restriction is a binary outcome defined as the occurrence or non-occurrence of growth restriction (defined as <5th percentile weight for gestational age, assessed specifically by sex and race of the infant based on United States birth certificate data)
  • Microcephaly [ Time Frame: Delivery ]
    Microcephaly is a binary outcome defined by the occurrence or non-occurrence of head circumference <3rd percentile for gestational age, assessed specifically by sex of the infant based on Olsen's data from a U.S. population
  • Symptomatic CMV infection [ Time Frame: During pregnancy up to 3 weeks postpartum ]
    Fetal or neonatal symptomatic CMV infection is a binary outcome defined as the occurrence or non-occurrence of symptomatic CMV infection defined as CMV isolated from an amniocentesis, or urine or saliva during the first three weeks of life and at least one of the following: jaundice (with direct bilirubin exceeding 20% of total bilirubin), thrombocytopenia , anemia , hepatitis, hepatomegaly, splenomegaly, growth restriction, failure to thrive, intracerebral calcifications, microcephaly, hypotonia, seizures, petechial rash, hearing loss, interstitial pneumonitis, thrombocytopenia, anemia, hepatitis, chorioretinitis, or CMV in cerebrospinal fluid
  • Intraventricular hemorrhage [ Time Frame: 0 days to approximately 120 days of life or hospital discharge, whichever is sooner ]
    Intraventricular hemorrhage (IVH) as determined by cranial ultrasounds performed as part of routine clinical care and classified based on the Papile classification system. IVH is a binary outcome defined by occurrence or non-occurrence of IVH
  • Ventriculomegaly [ Time Frame: 0 days to approximately 120 days of life or hospital discharge, whichever is sooner ]
    Ventriculomegaly is a binary outcome defined by the occurrence or non-occurrence of ventriculomegaly
  • Retinopathy of prematurity (ROP) [ Time Frame: 0 days to approximately 120 days of life or hospital discharge, whichever is sooner ]
    Retinopathy of prematurity is a binary outcome defined by the occurrence or non-occurrence of retinopathy of prematurity, diagnosed by ophthalmologic examination of the retina and a diagnosis of Stage I (demarcation line in the retina) or greater.
  • Respiratory distress syndrome [ Time Frame: 0 days to approximately 120 days of life or hospital discharge, whichever is sooner ]
    Respiratory distress syndrome is a binary outcome defined by the occurrence or non-occurrence of Respiratory distress syndrome (defined as the presence of clinical signs of respiratory distress (tachypnea, retractions, flaring, grunting, or cyanosis), with an oxygen requirement and a chest x-ray that shows hypoventilation and reticulogranular infiltrates).
  • Chronic lung disease [ Time Frame: 28 days of life ]
    Neonatal chronic lung disease is a binary outcome defined by the occurrence or non-occurrence of chronic lung disease or bronchopulmonary dysplasia (BPD) defined as oxygen requirement at 28 days of life
  • Necrotizing enterocolitis (NEC) [ Time Frame: 0 days to approximately 120 days of life or hospital discharge, whichever is sooner ]
    Necrotizing enterocolitis (NEC) is a binary outcome defined by the occurrence or non-occurrence of NEC, defined as modified Bell Stage 2 or 3. Stage 2: Clinical signs and symptoms with pneumatosis intestinalis on radiographs. Stage 3: Advanced clinical signs and symptoms, pneumatosis, impending or proven intestinal perforation.
  • Hyperbilirubinemia [ Time Frame: From birth to 1 week of life ]
    Hyperbilirubinemia is a binary outcome defined by the occurrence or non-occurrence of hyperbilirubinemia. Peak total bilirubin of at least 15 mg% or the use of phototherapy
  • Early neonatal sepsis [ Time Frame: 0 days of life to 72 hours of birth ]
    Early neonatal sepsis is a binary outcome defined as the occurrence or non-occurrence of sepsis occurring before 72 hours of birth
  • Late neonatal sepsis [ Time Frame: Greater than 72 hours of birth to approximately 120 days of life or hospital discharge, whichever is sooner ]
    Late neonatal sepsis is a binary outcome defined as the occurrence or non-occurrence of sepsis occurring late than 72 hours of birth
  • Suspected neonatal sepsis [ Time Frame: 0 days to approximately 120 days of life or hospital discharge, whichever is sooner ]
    Suspected neonatal sepsis is a binary outcome defined as the occurrence or non-occurrence of suspected neonatal sepsis
  • Neonatal pneumonia [ Time Frame: 0 days to approximately 120 days of life or hospital discharge, whichever is sooner ]
    Neonatal pneumonia is a binary outcome defined as the occurrence or non-occurrence of neonatal pneumonia
  • Seizures / encephalopathy [ Time Frame: 0 days to approximately 120 days of life or hospital discharge, whichever is sooner ]
    Neonatal seizures/encephalopathy is a binary outcome defined as the occurrence or non-occurrence of seizures/encephalopathy
  • Neonatal Length of hospital stay [ Time Frame: birth to neonatal hospital discharge (usually a maximum of 120 days) ]
    Length of hospital stay, need for Neonatal Intensive Care Unit (NICU) or intermediate care admission and length of stay if admitted
  • Infant or child death [ Time Frame: Birth to 24 month study exam ]
    Death of infant or child before the 24 month study exam
  • Sensorineural hearing loss [ Time Frame: 12 and 24 months corrected age ]
    Sensorineural hearing loss is defined as the occurrence or non-occurrence of sensorineural hearing loss defined as unilateral and bilateral sensorineural hearing loss
  • Chorioretinitis [ Time Frame: 2 years of age ]
    Chorioretinitis is defined as the occurrence or non-occurrence of chorioetinitis defined by ophthalmologic exam
  • Cognitive and Motor Scores from the Bayley Certified Scales of Infant Development III [ Time Frame: 12 and 24 months corrected age ]
  • Infant/Child composite outcome [ Time Frame: 24 month study exam ]
    Composite outcome at 24 months including any of the following attributable to congenital CMV infection: • Sensorineural hearing loss (unilateral and bilateral) • Developmental delay defined as Cognitive score < 70 or Motor score < 70 on the Bayley III • Chorioretinitis • Fetal loss or death of neonate, infant or child
  • Child status at 24 months of age [ Time Frame: 24 month study exam ]
    Child status at age 24 months, classified as: • Fetal loss or death of neonate, infant or child • Congenital CMV infection with severe disability • Congenital CMV infection without severe disability • Infant not infected with CMV
  • Failure to thrive [ Time Frame: 12 months and 24 months of age ]
    Failure to thrive defined as <10th percentile for weight at 12 and 24 months
  • Child viral load [ Time Frame: 12 and 24 months of age ]
    Viral load is defined as the amount of cytomegalovirus in copies/mL
Original Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2011)
  • Gestational hypertension [ Time Frame: 42 weeks of pregnancy ]
  • Preeclampsia [ Time Frame: 42 weeks of pregnancy ]
  • Placental abruption [ Time Frame: 42 weeks of pregnancy ]
  • Gestational age at delivery [ Time Frame: 42 weeks of pregnancy ]
    Gestational age at delivery and preterm birth < 37 weeks' gestation or < 34 weeks' gestation
  • Adverse reactions and side effects [ Time Frame: Up to 42 weeks of pregnancy ]
  • Fetal and neonatal mortality [ Time Frame: 24 months ]
  • Primary outcome excluding terminations [ Time Frame: 3 weeks of life ]
  • Head circumference [ Time Frame: 3 days of life ]
    Measured within 72 hours of birth
  • Birth weight [ Time Frame: 1 day of life ]
  • Growth restriction [ Time Frame: 1 day of life ]
    Growth restriction defined as <5th percentile weight for gestational age, assessed specifically by sex and race of the infant based on United States birth certificate data
  • Microcephaly [ Time Frame: 3 days of life ]
  • Symptomatic CMV infection [ Time Frame: 3 weeks of life ]
    Symptomatic CMV infection defined as CMV isolated from an amniocentesis, or urine or saliva during the first three weeks of life and at least one of the following: jaundice, hepatomegaly, splenomegaly, growth restriction, failure to thrive, intracerebral calcifications, microcephaly, hypotonia, seizures, petechial rash, hearing loss, interstitial pneumonitis, thrombocytopenia, anemia, hepatitis, chorioretinitis, or CMV in cerebrospinal fluid
  • Intraventricular hemorrhage [ Time Frame: 1 day of life ]
    Intraventricular hemorrhage (IVH) as determined by cranial ultrasounds performed as part of routine clinical care and classified based on the Papile classification system
  • Ventriculomegaly [ Time Frame: 1 day of life ]
  • Retinopathy of prematurity [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
    This diagnosis will be reached when an ophthalmologic examination of the retina has been performed and ROP is diagnosed at Stage I (demarcation line in the retina) or greater.
  • Respiratory distress syndrome [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
    Respiratory distress syndrome (RDS) defined as the presence of clinical signs of respiratory distress (tachypnea, retractions, flaring, grunting, or cyanosis), with an oxygen requirement and a chest x-ray that shows hypoaeration and reticulogranular infiltrates.
  • Chronic lung disease [ Time Frame: 28 days of life ]
    Chronic lung disease (BPD) defined as oxygen requirement at 28 days of life.
  • Necrotizing enterocolitis [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
    NEC, defined as modified Bell Stage 2 or 3. Stage 2: Clinical signs and symptoms with pneumatosis intestinalis on radiographs. Stage 3: Advanced clinical signs and symptoms, pneumatosis, impending or proven intestinal perforation.
  • Hyperbilirubinemia [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
    Peak total bilirubin of at least 15 mg% or the use of phototherapy
  • Neonatal infectious morbidity [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
    • Sepsis (within 72 hours and > 72 hours after birth).
    • Suspected sepsis.
    • Pneumonia.
  • Seizures / encephalopathy [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
  • Length of hospital stay [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
    Length of hospital stay, need for NICU or intermediate care admission and length of stay if admitted
  • Infant or child death [ Time Frame: 2 years of age ]
  • Sensorineural hearing loss [ Time Frame: 12 and 24 months corrected age ]
    (unilateral and bilateral)
  • Chorioretinitis [ Time Frame: 2 years of age ]
    Chorioretinitis defined by ophthalmologic exam
  • Cognitive and Motor Scores from the Bayley Certified Scales of Infant Development III [ Time Frame: 12 and 24 months corrected age ]
  • Infant/Child composite outcome [ Time Frame: 2 years of age ]
    Composite outcome at 24 months including any of the following attributable to congenital CMV infection:
    • Sensorineural hearing loss (unilateral and bilateral)
    • Developmental delay defined as Cognitive score < 70 or Motor score < 70 on the Bayley III
    • Chorioretinitis
    • Fetal loss or death of neonate, infant or child
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV)
Official Title  ICMJE A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV)
Brief Summary

Cytomegalovirus (CMV) is a common virus that usually presents with few if any side effects. When first infected, some people may have symptoms similar to mononucleosis (i.e., fatigue, weakness, fever, swollen glands). Most people in the United States are infected during childhood or as adults if they work around children. Pregnant women, who have not been infected with CMV in the past and become infected during pregnancy (i.e. a primary infection), may cause their babies to get infected with CMV. Babies that are infected may develop permanent disabilities including hearing loss and a small portion will die from the infection.

Currently it is not routine practice to screen pregnant women for CMV infection. Additionally, there is no agreement about how to evaluate and manage pregnant women infected with CMV for the first time. There is also no evidence that treatment is beneficial for the baby.

The purpose of this research study is to determine whether treating pregnant women who have a primary CMV infection with CMV antibodies will reduce the number of babies infected with CMV.

Detailed Description

Cytomegalovirus (CMV) is the most common congenital infection, with approximately 44,000 congenitally infected infants in the U.S. per year. A substantial proportion of these infants will die or suffer permanent injury as a result of their infection. The severity of congenital infection is greatest with primary maternal CMV infection. Currently, there is no proven method of preventing congenital CMV infection, and the approach to primary maternal CMV infection in the United States is haphazard and ineffective. One small, non-randomized study suggests that maternal administration of CMV hyperimmune globulin may significantly reduce the rate of congenital CMV infection following maternal primary infection. The MFMU CMV Trial will address the primary research question: does maternal administration of CMV hyperimmune globulin lower the rate of congenital CMV infection among the offspring of women who have been diagnosed with primary CMV infection during early pregnancy?

The research study is funded by the Eunice Kennedy Shriver National Institutes of Child Health and Human Development (NICHD). Sixteen medical centers across the country are participating in this research study. In all, 800 pregnant women who are identified with a primary CMV infection will be enrolled in this research study. The children of these women will be evaluated and tested at one and two years of age.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Congenital Cytomegalovirus Infection
  • Maternal Cytomegalovirus Infection
Intervention  ICMJE
  • Drug: CMV hyperimmune globulin
    The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
    Other Names:
    • CMV-IGIV
    • Cytogam
  • Other: Placebo
    The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
Study Arms  ICMJE
  • Active Comparator: CMV hyperimmune globulin - Cytogam®
    Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
    Intervention: Drug: CMV hyperimmune globulin
  • Placebo Comparator: Placebo
    IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
    Intervention: Other: Placebo
Publications * Hughes BL, Clifton RG, Rouse DJ, Saade GR, Dinsmoor MJ, Reddy UM, Pass R, Allard D, Mallett G, Fette LM, Gyamfi-Bannerman C, Varner MW, Goodnight WH, Tita ATN, Costantine MM, Swamy GK, Gibbs RS, Chien EK, Chauhan SP, El-Sayed YY, Casey BM, Parry S, Simhan HN, Napolitano PG, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. A Trial of Hyperimmune Globulin to Prevent Congenital Cytomegalovirus Infection. N Engl J Med. 2021 Jul 29;385(5):436-444. doi: 10.1056/NEJMoa1913569.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 14, 2020)
399
Original Estimated Enrollment  ICMJE
 (submitted: June 16, 2011)
800
Actual Study Completion Date  ICMJE June 30, 2021
Actual Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of primary maternal CMV infection on the basis of one of the following:

    1. A positive CMV Immunoglobulin M (IgM) antibody and low-avidity maternal CMV Immunoglobulin G (IgG) antibody screen
    2. Evidence of maternal seroconversion with development of CMV IgG antibody following a prior negative CMV screen
  • Gestational age at randomization no later than 23 weeks 6 days based on clinical information and evaluation of the earliest ultrasound; or no later than 27 weeks 6 days for women with a positive IgM, negative IgG initially screened before 23 weeks who are rescreened after 2-4 weeks and have evidence of IgG seroconversion.
  • Singleton pregnancy. A twin pregnancy reduced to singleton (either spontaneously or therapeutically) before 14 weeks by project gestational age is acceptable.

Exclusion Criteria:

  • Maternal CMV infection pre-dating pregnancy as defined by a high IgG avidity index or a positive IgG in the presence of a negative IgM.
  • Known hypersensitivity to plasma or plasma derived products
  • Planned termination of pregnancy
  • Known major fetal anomalies or demise
  • Maternal Immunoglobulin A (IgA) deficiency
  • Planned use of immune globulin, ganciclovir, or valganciclovir
  • Maternal renal disease (most recent pre-randomization serum creatinine ≥ 1.4 mg/dL; all women must have serum creatinine measured during the pregnancy and prior to randomization)
  • Maternal immune impairment (e.g., HIV infection, organ transplant on anti-rejection medications)
  • Findings on pre-randomization ultrasound suggestive of established fetal CMV infection (cerebral ventriculomegaly, microcephaly, cerebral or intra-abdominal calcifications, abnormalities of amniotic fluid volume, echogenic bowel or ascites). Abnormally low amniotic fluid volume is defined as no fluid prior to 14 weeks or maximum vertical pocket < 2 cm on or after 14 weeks gestation. Abnormally high amniotic fluid volume is defined as > 10 cm.
  • Positive fetal CMV findings from culture (amniotic fluid) or PCR.
  • Congenital infection with rubella, syphilis, varicella, parvovirus or toxoplasmosis diagnosed by serology and ultrasound or amniotic fluid testing.
  • Intention of the patient or of the managing obstetricians for the delivery to be outside a Maternal-Fetal Medicine Units Network (MFMU) Network center
  • Participation in another interventional study that influences fetal or neonatal death
  • Unwilling or unable to commit to 2 year follow-up of the infant
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01376778
Other Study ID Numbers  ICMJE HD36801-CMV
U10HD036801 ( U.S. NIH Grant/Contract )
U10HD027869 ( U.S. NIH Grant/Contract )
U10HD027915 ( U.S. NIH Grant/Contract )
U10HD034116 ( U.S. NIH Grant/Contract )
U10HD034208 ( U.S. NIH Grant/Contract )
U10HD040500 ( U.S. NIH Grant/Contract )
U10HD040485 ( U.S. NIH Grant/Contract )
U10HD040544 ( U.S. NIH Grant/Contract )
U10HD040545 ( U.S. NIH Grant/Contract )
U10HD040560 ( U.S. NIH Grant/Contract )
U10HD040512 ( U.S. NIH Grant/Contract )
U10HD053097 ( U.S. NIH Grant/Contract )
U10HD068282 ( U.S. NIH Grant/Contract )
U10HD068258 ( U.S. NIH Grant/Contract )
U10HD068268 ( U.S. NIH Grant/Contract )
UG1HD087230 ( U.S. NIH Grant/Contract )
UG1HD087192 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: The dataset will be shared per NIH policy after the completion and publication of the main analyses. Requests for datasets can be sent to mfmudatasets@bsc.gwu.edu.
Responsible Party The George Washington University Biostatistics Center
Study Sponsor  ICMJE The George Washington University Biostatistics Center
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Study Director: Andrew Bremer, M.D., MPH Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Rebecca Clifton, PhD George Washington University
Study Chair: Brenna Hughes, MD Brown University
PRS Account The George Washington University Biostatistics Center
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP