Delayed Cord Clamping in Rhesus Disease of the Newborn

Study Overview
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Brief Summary
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The objective of this clinical trial is to investigate the effects of delayed cord clamping on hyperbilirubinemia, the need for phototherapy, neonatal intensive care (NICU) admission

Detailed Description
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The study will include term or preterm infants born to Rh negative mother. The enrolled infants will be randomized into two groups: Group (1) will include infants with delayed cord clamping performed at 60 sec after birth Group (2) will include infants with early cord clamping within 15 seconds. History and examination The data on the gender, gestational age, birth weight, length, head circumference, 5- minute Apgar scores, presence of jaundice requiring phototherapy or exchange transfusion, need for admission in neonatal intensive care unit, the presence of respiratory distress (RR > 60 breath per minute) ,and length of hospitalization will be recorded. The enrolled infants will be followed either with their mothers in the nursery or in NICU. Regarding the mothers; maternal age, maternal weight, any diseases, medication, and mode of delivery, and postpartum hemorrhage requiring blood transfusion will be recorded.

Official Title
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Delayed Cord Clamping in Rhesus Disease of the Newborn: A Randomized Clinical Trial

Conditions
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Rhesus Isoimmunization

Intervention / Treatment
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* Procedure: Delayed cord clamping
* Procedure: Early cord clamping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - term or preterm infants born to Rh negative mother Exclusion Criteria: Infants with Rh negative factor major congenital malformation fetal hydrops short umbilical cord less than 25cm nuchal cord multiple gestation unstable maternal hemodynamic condition placenta abruption placenta previa uterine rupture denied to participate depressed neonates who will require immediate resuscitation

Ages Eligible for Study
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Maximum Age: 1 Minute

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: delayed cord clamping<br>DCC performed at 60 sec after birth | Procedure: Delayed cord clamping<br>* DCC performed at 60 sec after birth<br>|
| Experimental: early cord clamping<br>ECC performed at 15 sec after birth | Procedure: Early cord clamping<br>* ECC performed at 15 sec after birth<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematocrit value | Hematocrit will be measured at 2 hours of life (percent %) | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bilirubin level | Bilirubin level will be measured at 24 hours of life (mg/dl) | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rhesus Disease, Newborn