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

Placental Transfusion Clinical Trial

— Term-NRIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02827409
• Other study ID #: Term-NRIC
• Status: Completed
• Phase: N/A
• First received: July 5, 2016
• Last updated: June 7, 2017
• Start date: July 2016
• Est. completion date: December 2016

Study information

• Verified date: June 2017
• Source: Sharp HealthCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 37 Weeks to 42 Weeks

Eligibility

• 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.

Related Conditions & MeSH terms

• Placental Transfusion

Intervention

Procedure:
• Short Delay Cord Clamping
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.
• Extended Delay Cord Clamping
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.

Locations

Country	Name	City	State
United States	Sharp Mary Birch Hospital for Women and Newborns	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Anup Katheria, M.D.

Country where clinical trial is conducted

United States, 

Outcome

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