Early or Late Cord Clamping in the Depressed Neonate

Study Overview
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Brief Summary
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This study evaluates the hypothesis that delayed compared to early umbilical cord clamping will improve neonatal transition in terms of circulation and breathing during resuscitation.

Detailed Description
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At the time of birth, the infant is still attached to the placenta via the umbilical cord. The infant is usually separated from the placenta by clamping the cord with two clamps. Early cord clamping has been generally advised to be carried out in the first 30 seconds after birth, regardless of whether the cord pulsation has ceased. However, arguments against early cord clamping include the reduction in the amount of placental transfusion and any associated benefits of extra blood volume, as delayed clamping allows time for a transfer of the fetal blood in the placenta to the infant at the time of birth. The study will evaluate the effect of early versus delayed cord clamping in a low-income setting in children that do not spontaneously start to breathe. The randomized controlled trial will be carried out at Paropakar Maternity and Women's Hospital (PMWH) in Kathmandu. The trial will fill several important gaps in relation to early and delayed cord clamping and results.

Official Title
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Early or Late Cord Clamping in the Depressed Neonate - a Randomized Controlled Study in a Low-income Facility Setting for Improved Early Neonatal Outcome

Conditions
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Neonatal Disorder, Asphyxia Neonatorum

Intervention / Treatment
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* Procedure: Early (≤ 60 seconds) cord clamping
* Procedure: Delayed (≥ 180 seconds) cord clamping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newborn in need of resuscitation measures (no or irregular breathing despite thorough drying and additional stimulation within one minute after birth) Gestational age ≥ 33 weeks Exclusion Criteria: Monochorionic twins (from an ultrasound scan) or clinical evidence of twin-twin transfusion syndrome, triplets or higher order multiple pregnancy, and fetuses with known congenital malformation

Ages Eligible for Study
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Minimum Age: 33 Weeks
Maximum Age: 42 Weeks

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early (≤ 60 seconds) cord clamping<br>Early (≤ 60 seconds) cord clamping | Procedure: Early (≤ 60 seconds) cord clamping<br>* If the infant don't breathe, the umbilical cord is clamped (≤ 60 seconds) and cut and resuscitation will be provided at a resuscitation table<br>* Other names: Immediate clamping;|
| Active Comparator: Delayed cord clamping<br>Delayed (≥ 180 seconds) cord clamping | Procedure: Delayed (≥ 180 seconds) cord clamping<br>* If the infant don't breathe, the umbilical cord is not clamped and cut until after 180 seconds. Initial resuscitation will be provided bedside to the mother<br>* Other names: Optimal cord clamping;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood oxygen saturation | Measured with a pulse oximeter | 10 minutes after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood oxygen saturation | Measured with a pulse oximeter | 5 minutes after birth | 
| Timing of reaching > 90 % in oxygen saturation | Measured with a pulse oximeter | Within 10 minutes after birth | 
| Newborn heart rate | Measured with a pulse oximeter (preferred), fetal heart monitor or manually | At 1 minute after birth | 
| Newborn heart rate | Measured with a pulse oximeter (preferred), fetal heart monitor or manually | At 5 minutes after birth | 
| Newborn heart rate | Measured with a pulse oximeter (preferred), fetal heart monitor or manually | At 10 minutes after birth | 
| Apgar score | Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes | At 1 minute after birth | 
| Apgar score | Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes | At 5 minutes after birth | 
| Apgar score | Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes | At 10 minutes after birth | 
| Pulsatility index | Measured with a pulse oximeter | At 5 minutes after birth | 
| Pulsatility index | Measured with a pulse oximeter | At 10 minutes after birth | 
| Timing of establishing spontaneous breathing | Assessed by staff present | Within 10 minutes after birth | 
| Timing of first cry | Assessed by staff present | Within 10 minutes after birth | 
| Timing of moving baby from mother to resuscitation table (if applicable | Assessed by staff present | Within 10 minutes after birth | 
| Rectal temperature | Assessed by staff present | At 30 minutes after birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resuscitation, Cord clamping