Generic Database of Moderate Preterm Infants
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| ClinicalTrials.gov Identifier: NCT01793116 |
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Recruitment Status :
Completed
First Posted : February 15, 2013
Last Update Posted : March 22, 2019
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| Condition or disease |
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| Infant, Newborn Infant, Moderate Preterm |
The Moderate Preterm Registry is a registry of moderate preterm infants (29-33 weeks gestational age) born alive in NICHD Neonatal Research Network (NRN) centers. The purpose is to collect baseline and outcome data in a uniform manner on a cohort of infants.
The registry collects observational baseline data on both mothers and infants, and the therapies used and outcomes of the infants. The information collected is not specific to a disease or treatment (i.e., it is "generic"). Baseline data is collected soon after admission to the NICU; outcome data is collected at the time of death or discharge from the hospital. The data collected includes information on:
- Demographics of mother and infant
- Mother's health (e.g., pregnancy history and complications)
- Labor and deliver (e.g., rupture of the membranes, steroids and antibiotics given, mode of delivery)
- Infant's health (gestational age, Apgar scores, weight, length, delivery room resuscitation, respiratory support, etc.)
- Infant's medical outcome (heart, lung, nervous system, gastrointestinal system, hearing, and vision, known infections, and major malformations/syndromes, and mortality or number of days hospitalized).
These data are used: to examine associations between baseline characteristics, treatments, and outcomes; to track trends in incidences of disease and effectiveness of therapies; and to identify questions requiring additional in-depth research.
Informed Consent: As required by local IRBs.
| Study Type : | Observational [Patient Registry] |
| Actual Enrollment : | 7057 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 11 Weeks |
| Official Title: | Time Limited Observational Study of the Moderately Preterm Infant (29 0/7 - 33 6/7 Weeks) |
| Study Start Date : | March 2012 |
| Actual Primary Completion Date : | October 2013 |
| Actual Study Completion Date : | February 2014 |
- Number of infants born moderately preterm [ Time Frame: up to 2 years ]Number of infants born between 29-33 weeks gestational age at 18 participating NRN centers.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 29 Weeks to 33 Weeks (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Gestational age 29-33 weeks
- Inborn infants and outborn infants admitted by 72 hours.
Exclusion Criteria:
- None
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01793116
Show 19 study locations
| Principal Investigator: | Abbot R Laptook, MD | Brown University, Women & Infants Hospital of Rhode Island | |
| Principal Investigator: | Michele C Walsh, MD, MS | Case Western Reserve University, Rainbow Babies and Children's Hospital | |
| Principal Investigator: | Ronald N Goldberg, MD | Duke University | |
| Principal Investigator: | Barbara J Stoll, MD | Emory University | |
| Principal Investigator: | Brenda B Poindexter, MD, MS | Indiana University | |
| Principal Investigator: | Abhik Das, PhD | RTI International | |
| Principal Investigator: | Krisa P Van Meurs, MD | Stanford University | |
| Principal Investigator: | Kurt Schibler, MD | Children's Hospital Medical Center, Cincinnati | |
| Principal Investigator: | Waldemar Carlo, MD | University of Alabama at Birmingha | |
| Principal Investigator: | Edward F Bell, MD | University of Iowa | |
| Principal Investigator: | Kristi L Watterberg, MD | University of New Mexico | |
| Principal Investigator: | Pablo J Sanchez, MD | University of Texas, Southwestern Medical Center at Dallas | |
| Principal Investigator: | Kathleen A Kennedy, MD, MPH | The University of Texas Health Science Center, Houston | |
| Principal Investigator: | Seetha Shankaran, MD | Wayne State University | |
| Principal Investigator: | William Truog, MD | Abbot R Laptook, MD Study Principal Investigator Brown University, Women & Infants Hospital of Rhode Island Michele C Walsh, MD MS Study Principal Investigator Case Western Reserve University, Rainbow Babies and Children's Hospital Ronald N Goldberg, | |
| Principal Investigator: | Barbara Schmidt, MD, MSc | University of Pennsylvania | |
| Principal Investigator: | Carl D'Angio, MD | University of Rochester | |
| Principal Investigator: | Uday Devaskar, MD | University of California, Los Angeles | |
| Principal Investigator: | Leif Nelin, MD | Research Institute at Nationwide Children's Hospital |
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NICHD Neonatal Research Network Moderately Preterm |
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Premature Birth Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications |