Asphyxia Neonatorum, Neonatal Disorder
Conditions
Keywords
Resuscitation, Cord clamping
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREEarly (≤ 60 seconds) cord clamping
If the infant don't breathe, the umbilical cord is clamped (≤ 60 seconds) and cut and resuscitation will be provided at a resuscitation table
PROCEDUREDelayed (≥ 180 seconds) cord clamping
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
Sponsors
UNICEF
Ministry of Health and Population, Nepal
Swedish Society for Medical Research
Uppsala University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
33 Weeks to 42 Weeks
Healthy volunteers
No
Inclusion criteria
* Newborn in need of resuscitation measures (no or irregular breathing despite thorough drying and additional stimulation within one minute after birth) * Gestational age ≥ 33 weeks
Exclusion criteria
Monochorionic twins (from an ultrasound scan) or clinical evidence of twin-twin transfusion syndrome, triplets or higher order multiple pregnancy, and fetuses with known congenital malformation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood oxygen saturation | 10 minutes after birth | Measured with a pulse oximeter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood oxygen saturation | 5 minutes after birth | Measured with a pulse oximeter |
| Timing of reaching > 90 % in oxygen saturation | Within 10 minutes after birth | Measured with a pulse oximeter |
| Newborn heart rate | At 1 minute after birth | Measured with a pulse oximeter (preferred), fetal heart monitor or manually |
| Apgar score | At 1 minute after birth | Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes |
| Timing of establishing spontaneous breathing | Within 10 minutes after birth | Assessed by staff present |
| Timing of first cry | Within 10 minutes after birth | Assessed by staff present |
| Timing of moving baby from mother to resuscitation table (if applicable | Within 10 minutes after birth | Assessed by staff present |
| Rectal temperature | At 30 minutes after birth | Assessed by staff present |
| Pulsatility index | At 5 minutes after birth | Measured with a pulse oximeter |
Other
| Measure | Time frame | Description |
|---|---|---|
| Presence at one day of age | 24 hours | The place of stay for newborn at one day of age |
Countries
Nepal
Outcome results
None listed