To determine whether performing extended delayed cord clamping in term neonates that require resuscitation improves early transition as compared to short-delayed cord clamping.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
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 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.
Sharp Mary Birch Hospital for Women and Newborns
San Diego, California, United States
Cerebral tissue oxygenation
The need for oxygen, positive pressure ventilation, intubation
Time frame: 12 hours of life
Heart rate
Heart rate obtained by pulse doppler, EKG, oximetry or a combination of all
Time frame: First 5 minutes of life
Oxygen saturation
data will be averaged over each minute of life
Time frame: 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.
Time frame: at birth
Blood pressure
Time frame: 12 hours of life
Hemoglobin
if Hemoglobin oximeter available
Time frame: First 5 minutes of life
Hemoglobin
if Hemoglobin oximeter available
Time frame: 12 hours of life
Apgar Score
1, 5 and 10 minute Apgar
Time frame: First 10 minutes of life
Arterial and Venous Umbilical Cord Blood Gases
Time frame: At birth
Need for NICU admission
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Time frame: at birth
Need for hypothermia for hypoxic ischemic encepalopathy
will be assessed by primary physician using defined criteria for hypothermia
Time frame: at birth
Hospitalization days
Time frame: up to 24 weeks
Bilirubin level
by transcutaneous or serum if available. percentile on curve will be document to adjust for different time frames.
Time frame: 12-48 hours
Neurodevelopmental impairment
by Ages and Stages questionnaire or Bayley 3scales of infant and toddler development
Time frame: 12 month followup
Post delivery survey
Survey of practitioners (LD nurse, OB, neonatal team) about procedure
Time frame: at birth