Short-Delay Cord Clamping Compared to Extended- Delay Cord Clamping in Term Neonates That Require Resuscitation.
- Conditions
- Placental Transfusion
- Interventions
- Procedure: Short Delay Cord ClampingProcedure: Extended Delay Cord Clamping
- Registration Number
- NCT02827409
- Lead Sponsor
- Anup Katheria, M.D.
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Gestation 37 weeks or greater that require attendance at delivery of neonatal provider due to an at risk delivery. *
Planned cesarean birth, placental abruption, multiple gestations, or known congenital anomalies.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Short Delay Cord Clamping Short Delay Cord Clamping Subject will have umbilical cord clamped and cut by 1 minute of life. Extended Delay Cord Clamping Extended Delay Cord Clamping 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
- Primary Outcome Measures
Name Time Method Cerebral tissue oxygenation 12 hours of life The need for oxygen, positive pressure ventilation, intubation
- Secondary Outcome Measures
Name Time Method Heart rate First 5 minutes of life Heart rate obtained by pulse doppler, EKG, oximetry or a combination of all
Oxygen saturation over the first 5 minutes of life data will be averaged over each minute of life
Arterial and Venous Umbilical Cord Blood Gases At birth Blood pressure 12 hours of life delivery room resuscitation at birth did the infant require resuscitation such as stimulation to breathe, oxygen, positive pressure ventilation etc.
Need for NICU admission at birth Hospitalization days up to 24 weeks Need for hypothermia for hypoxic ischemic encepalopathy at birth will be assessed by primary physician using defined criteria for hypothermia
Hemoglobin 12 hours of life if Hemoglobin oximeter available
Apgar Score First 10 minutes of life 1, 5 and 10 minute Apgar
Neurodevelopmental impairment 12 month followup by Ages and Stages questionnaire or Bayley 3scales of infant and toddler development
Bilirubin level 12-48 hours by transcutaneous or serum if available. percentile on curve will be document to adjust for different time frames.
Post delivery survey at birth Survey of practitioners (LD nurse, OB, neonatal team) about procedure
Trial Locations
- Locations (1)
Sharp Mary Birch Hospital for Women and Newborns
🇺🇸San Diego, California, United States