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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
90
If the infant don't breathe, the umbilical cord is clamped (≤ 60 seconds) and cut and resuscitation will be provided at a resuscitation table
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
Paropakar Maternity and Women's Hospital
Kathmandu, Nepal
Blood oxygen saturation
Measured with a pulse oximeter
Time frame: 10 minutes after birth
Blood oxygen saturation
Measured with a pulse oximeter
Time frame: 5 minutes after birth
Timing of reaching > 90 % in oxygen saturation
Measured with a pulse oximeter
Time frame: Within 10 minutes after birth
Newborn heart rate
Measured with a pulse oximeter (preferred), fetal heart monitor or manually
Time frame: At 1 minute after birth
Newborn heart rate
Measured with a pulse oximeter (preferred), fetal heart monitor or manually
Time frame: At 5 minutes after birth
Newborn heart rate
Measured with a pulse oximeter (preferred), fetal heart monitor or manually
Time frame: At 10 minutes after birth
Apgar score
Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes
Time frame: At 1 minute after birth
Apgar score
Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes
Time frame: At 5 minutes after birth
Apgar score
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Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes
Time frame: At 10 minutes after birth
Pulsatility index
Measured with a pulse oximeter
Time frame: At 5 minutes after birth
Pulsatility index
Measured with a pulse oximeter
Time frame: At 10 minutes after birth
Timing of establishing spontaneous breathing
Assessed by staff present
Time frame: Within 10 minutes after birth
Timing of first cry
Assessed by staff present
Time frame: Within 10 minutes after birth
Timing of moving baby from mother to resuscitation table (if applicable
Assessed by staff present
Time frame: Within 10 minutes after birth
Rectal temperature
Assessed by staff present
Time frame: At 30 minutes after birth