Short-Delay Cord Clamping Compared to Extended- Delay Cord Clamping in Term Neonates That Require Resuscitation.

Study Overview
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Brief Summary
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To determine whether performing extended delayed cord clamping in term neonates that require resuscitation improves early transition as compared to short-delayed cord clamping.

Detailed Description
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All subjects will receive delayed cord clamping. One group (short-delay) will receive up to one minute of delayed cord clamping and then will be placed either on the mother's abdomen or the life-start trolley if extensive resuscitation is required. The second group will receive delayed cord clamping for at least 5 minutes and continue until the baby has established breathing without additional support or is stable on respiratory support (no longer received mask PPV for at least 1-2 minutes, i.e. stable on CPAP or intubated). The subject will initially be placed on the mother's abdomen or if the subject needs extensive resuscitation they will be moved to the LifeStart bed to receive resuscitation measures. In either group if the baby is deemed to be unstable (by medical team) to be on the life-start trolley the cord will be clamped and the baby will be moved to an adjacent warmer for resuscitation.

Official Title
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A Randomized Controlled Trial of Short-Delay Cord Clamping as Compared to Extended- Delayed Cord Clamping in Term Neonates That Require Resuscitation.

Conditions
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Placental Transfusion

Intervention / Treatment
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* Procedure: Short Delay Cord Clamping
* Procedure: Extended Delay Cord Clamping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestation 37 weeks or greater that require attendance at delivery of neonatal provider due to an at risk delivery. Exclusion Criteria: Planned cesarean birth, placental abruption, multiple gestations, or known congenital anomalies.

Ages Eligible for Study
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Minimum Age: 37 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Short Delay Cord Clamping<br>Subject will have umbilical cord clamped and cut by 1 minute of life. | Procedure: Short Delay Cord Clamping<br>* Delay cord clamping will occur for up to 1 minute. Subject will be placed on mother's abdomen for warmth and stimulation. If the subject is depressed they will be transferred to the radiant warmer for resuscitation.<br>|
| Active Comparator: Extended Delay Cord Clamping<br>Subject will have umbilical cord clamped and cut after at least 5 minutes of delayed cord clamping. Duration of cord clamping after 5 minutes will depend on if the subject is breathing and/or if the cord has stopped pulsating | Procedure: Extended Delay Cord Clamping<br>* Extended delay cord clamping will occur for at least 5 minutes and will continue until the subjects begins breathing and/or the cord stops pulsating. Subject will be placed on mother's abdomen for warmth and stimulation. If the subject is depressed they will be transferred to the LifeStart bed for resuscitation adjacent to the mother's bedside.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral tissue oxygenation | The need for oxygen, positive pressure ventilation, intubation | 12 hours of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | Heart rate obtained by pulse doppler, EKG, oximetry or a combination of all | First 5 minutes of life | 
| Oxygen saturation | data will be averaged over each minute of life | over the first 5 minutes of life | 
| delivery room resuscitation | did the infant require resuscitation such as stimulation to breathe, oxygen, positive pressure ventilation etc. | at birth | 
| Blood pressure |  | 12 hours of life | 
| Hemoglobin | if Hemoglobin oximeter available | First 5 minutes of life | 
| Hemoglobin | if Hemoglobin oximeter available | 12 hours of life | 
| Apgar Score | 1, 5 and 10 minute Apgar | First 10 minutes of life | 
| Arterial and Venous Umbilical Cord Blood Gases |  | At birth | 
| Need for NICU admission |  | at birth | 
| Need for hypothermia for hypoxic ischemic encepalopathy | will be assessed by primary physician using defined criteria for hypothermia | at birth | 
| Hospitalization days |  | up to 24 weeks | 
| Bilirubin level | by transcutaneous or serum if available. percentile on curve will be document to adjust for different time frames. | 12-48 hours | 
| Neurodevelopmental impairment | by Ages and Stages questionnaire or Bayley 3scales of infant and toddler development | 12 month followup | 
| Post delivery survey | Survey of practitioners (LD nurse, OB, neonatal team) about procedure | at birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delayed cord clamping