Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of Umbilical Cord Milking in Preterm Neonates With Placental Insufficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03731611
Recruitment Status : Recruiting
First Posted : November 6, 2018
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Nehad Nasef, Mansoura University Children Hospital

Brief Summary:
To investigate the effect of umbilical cord milking (UCM) on peripheral hematologic parameters including hematopoietic progenitor cells in premature infants ≤ 34 weeks gestational age with placental insufficiency. We hypothesize that UCM would enhance peripheral CD34 concentration, hemoglobin and reduce prematurity complications like NEC and IVH in preterm infant ≤ 34 week gestational age with placental insufficiency.

Condition or disease Intervention/treatment Phase
Placental Insufficiency Preterm Infant Procedure: Umbilical Cord Milking Not Applicable

Detailed Description:

A pilot prospective randomized controlled study will be conducted among 3 groups, all of them are preterm less than 34 weeks gestational age, in the first group umbilical cord milking will be done for preterm infant with placental insufficiency. Two control groups are present, in the first one umbilical cord milking will be done for preterm infants without placental insufficiency (Insufficiency vs. no insufficiency), another group of immediate cord clamping for preterm infants with placental insufficiency will be added (milking vs. no milking), 30 cases will be recruited in each group.

Umbilical cord milking (UCM) is typically performed by placing the infant below the level of the placenta. The cord is held at 20-25 cm distance from the baby and milked vigorously towards the umbilicus for 3 times at a speed of 10 cm/sec. After completion, the cord is clamped, and the neonate is handed to the resuscitation team.

One milliliter of fetal blood will be taken from peripheral venous blood in the first 30 min of life and CD34 will be assessed by flow cytometry. Secondary outcomes will be documented during NICU stay that include admission CBC, peak bilirubin concentrations, CBC after 2 months, neonatal morbidity such as sepsis, bronchopulmonary dysplasia, necrotizing enterocolitis, retinopathy of prematurity and polycythemia, therapeutic interventions such as need for inotropes, nasal CPAP, mechanical ventilation and phototherapy.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Umbilical Cord Milking in Preterm Neonates With Placental Insufficiency
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group A
umbilical cord milking will be done for preterm infants <34 gestational age without placental insufficiency
Procedure: Umbilical Cord Milking
Umbilical cord milking (UCM) is typically performed by placing the infant below the level of the placenta. The cord is held at 20-25 cm distance from the baby and milked vigorously towards the umbilicus for 3 times at a speed of 10 cm/sec. After completion, the cord is clamped, and the neonate is handed to the resuscitation team.

Active Comparator: Group B
umbilical cord milking will be done for preterm infant <34 gestational age with placental insufficiency
Procedure: Umbilical Cord Milking
Umbilical cord milking (UCM) is typically performed by placing the infant below the level of the placenta. The cord is held at 20-25 cm distance from the baby and milked vigorously towards the umbilicus for 3 times at a speed of 10 cm/sec. After completion, the cord is clamped, and the neonate is handed to the resuscitation team.

No Intervention: Group C
Immediate cord clamping for preterm infants <34 gestational age with placental insufficiency



Primary Outcome Measures :
  1. Peripheral venous CD34 at admission [ Time Frame: first 24 hours of infants' life ]
    One milliliter of fetal blood will be taken from peripheral venous blood in the first 30 min of life and CD34 will be assessed by flow cytometry.


Secondary Outcome Measures :
  1. Admission hemoglobin [ Time Frame: first 24 hours of infants' life ]
    One milliliter of neonatal blood will be taken from peripheral venous blood in the first 24 hours of life.

  2. Hemoglobin at 2 months [ Time Frame: 2 months after umbilical cord milking ]
    One milliliter of neonatal blood will be taken from peripheral venous blood at 2 months of life.

  3. Admission platelets [ Time Frame: first 24 hours of infants' life ]
    One milliliter of neonatal blood will be taken from peripheral venous blood in the first 24 hours of life.

  4. Admission WBCs [ Time Frame: first 24 hours of infants' life ]
    One milliliter of neonatal blood will be taken from peripheral venous blood in the first 24 hours of life.

  5. Phototherapy requirements [ Time Frame: first 28 days of life ]
    Need to start phototherapy for hyperbilirubinemia

  6. Polycythemia [ Time Frame: first 28 days of life ]
    arterial Hematocrit value more than 70%

  7. Culture proven sepsis [ Time Frame: first 28 days of life ]
    Sepsis confirmed by positive blood culture

  8. Necrotizing enterocolitis [ Time Frame: first 28 days of life ]
    Necrotizing enterocolitis (Any Bell's stage)

  9. Intraventricular hemorrhage [ Time Frame: first 28 days of life ]
    Intraventricular hemorrhage of all grades

  10. Bronchopulmonary dysplasia [ Time Frame: first 70 days of life ]
    Oxygen requirement at 36 weeks corrected gestational age

  11. Need for packed RBCs transfusion [ Time Frame: first 28 days of life ]
    number of packed RBCs transfusion

  12. Retinopathy of prematurity [ Time Frame: first 28 days of life ]
    Prethreshold and threshold diseases Retinopathy of prematurity

  13. Need for inotropes [ Time Frame: first 28 days of life ]
    Hypotension requiring inotropic support

  14. Need for nasal CPAP [ Time Frame: first 28 days of life ]
    respiratory distress requiring CPAP support

  15. Need for mechanical ventilation [ Time Frame: first 28 days of life ]
    respiratory distress requiring mechanical ventilation support

  16. Duration of oxygen therapy [ Time Frame: first 70 days of life ]
    Duration of oxygen therapy



Information from the National Library of Medicine

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.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • preterm neonates < 34 weeks gestational age

Exclusion Criteria:

  • Vaginal bleeding due to placental abruption or tears
  • Multiple pregnancies
  • Suspected major fetal anomalies
  • Suspected chromosomal aberration
  • Maternal drug abuse
  • Hydrops fetalis
  • preterm who needed major resuscitative measures

Information from the National Library of Medicine

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): NCT03731611


Contacts
Layout table for location contacts
Contact: Islam Nour, MD +201003893026 inour2001@gmail.com

Locations
Layout table for location information
Egypt
Mansoura University Children Hospital Recruiting
Mansourah, El Dakahlya, Egypt, 35111
Contact: nehad a nasef, MD    01001229299 ext 002    nehad_nasef@yahoo.com   
Mansoura University Children's Hospital Recruiting
Mansourah, Egypt
Sponsors and Collaborators
Mansoura University Children Hospital
Publications of Results:
Layout table for additonal information
Responsible Party: Nehad Nasef, Professor of pediatrics/Neonatology, Mansoura University Children Hospital
ClinicalTrials.gov Identifier: NCT03731611    
Other Study ID Numbers: MS/17.07.44
First Posted: November 6, 2018    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nehad Nasef, Mansoura University Children Hospital:
Umbilical cord milking
Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Birth
Placental Insufficiency
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases