Clinical trial NCT02727517: Early or Late Cord Clamping in the Depressed Neonate
Official title: Early or Late Cord Clamping in the Depressed Neonate - a Randomized Controlled Study in a Low-income Facility Setting for Improved Early Neonatal Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Disorder
Asphyxia Neonatorum
Keywords: Resuscitation
Cord clamping
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: UNICEF
name: Ministry of Health and Population, Nepal
name: Swedish Society for Medical Research
First posted: 2016-04-04
Enrollment: 90
Sex: ALL
Minimum age (years): 33
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood oxygen saturation
timeFrame: 10 minutes after birth
Secondary outcomes:
measure: Blood oxygen saturation
timeFrame: 5 minutes after birth
measure: Timing of reaching > 90 % in oxygen saturation
timeFrame: Within 10 minutes after birth
measure: Newborn heart rate
timeFrame: At 1 minute after birth
measure: Newborn heart rate
timeFrame: At 5 minutes after birth
measure: Newborn heart rate
timeFrame: At 10 minutes after birth
measure: Apgar score
timeFrame: At 1 minute after birth
measure: Apgar score
timeFrame: At 5 minutes after birth
measure: Apgar score
timeFrame: At 10 minutes after birth
measure: Pulsatility index
timeFrame: At 5 minutes after birth
measure: Pulsatility index
timeFrame: At 10 minutes after birth
measure: Timing of establishing spontaneous breathing
timeFrame: Within 10 minutes after birth
measure: Timing of first cry
timeFrame: Within 10 minutes after birth
measure: Timing of moving baby from mother to resuscitation table (if applicable
timeFrame: Within 10 minutes after birth
measure: Rectal temperature
timeFrame: At 30 minutes after birth
Other outcomes:
measure: Presence at one day of age
timeFrame: 24 hours
Locations:
city: Kathmandu
country: Nepal
facility: Paropakar Maternity and Women's Hospital
Study officials:
affiliation: Uppsala University
name: Ashish KC, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Uppsala University
name: Ola Andersson, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Niermeyer S, Velaphi S. Promoting physiologic transition at birth: re-examining resuscitation and the timing of cord clamping. Semin Fetal Neonatal Med. 2013 Dec;18(6):385-92. doi: 10.1016/j.siny.2013.08.008. Epub 2013 Sep 19.
citation: Xodo S, Xodo L, Baccarini G, Driul L, Londero AP. Does Delayed Cord Clamping Improve Long-Term (>/=4 Months) Neurodevelopment in Term Babies? A Systematic Review and a Meta-Analysis of Randomized Clinical Trials. Front Pediatr. 2021 Apr 12;9:651410. doi: 10.3389/fped.2021.651410. eCollection 2021.
citation: Andersson O, Rana N, Ewald U, Malqvist M, Stripple G, Basnet O, Subedi K, Kc A. Intact cord resuscitation versus early cord clamping in the treatment of depressed newborn infants during the first 10 minutes of birth (Nepcord III) - a randomized clinical trial. Matern Health Neonatol Perinatol. 2019 Aug 29;5:15. doi: 10.1186/s40748-019-0110-z. eCollection 2019.