Kangaroo Mother Care Before Stabilisation Amongst Low Birth Weight Neonates in Africa

Launched by LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE · Jun 21, 2016

Keywords

ClinConnect Summary

METHODS Study setting, design, and participants The OMWaNA trial was an individually randomised, controlled, superiority trial with two parallel arms allocated in a 1:1 ratio to receive KMC initiated before stabilisation (intervention) or standard care (control). The trial was conducted in the neonatal units (WHO level-2) of five government hospitals in Uganda (appendix p 5). Infrastructure and equipment improvements as well as training were required prior to trial initiation, as described previously.10 All hospitals were provided with essential equipment and supplies to support the provisi...

Gender

ALL

Eligibility criteria

• • Inclusion criteria
• • Liveborn at Jinja Hospital, Masaka Hospital, Entebbe Hospital, or Iganga Hospital
• • Singleton or twin pregnancy
• • Birthweight ≥700g and ≤2000g
• • Chronological age 1-48 hours at time of screening
• • Alive at time of recruitment
• • Parent/caregiver able and willing to provide KMC
• • Parent/caregiver willing to attend follow-up visit
• • Indication for KMC "uncertain" according to WHO guideline concerning clinical stability: pragmatically defined as receiving ≥1 therapy: oxygen, CPAP, IV fluids, therapeutic antibiotics, phenobarbital
• • Exclusion criteria
• • Outborn
• • Result of triplet or higher order multifetal pregnancy
• • Indication for KMC "certain" according to WHO guidelines: pragmatically defined as clinically well neonates receiving none of the above therapy-based criteria
• * Severely life-threatening instability defined as SpO2 \<88% in oxygen AND ≥1 of:
• • Respiratory rate \<20 or \>100 breaths/min
• • Apnoea requiring bag-mask ventilation
• • HR \<100 or \>200 bpm
• • Severe jaundice requiring immediate management
• • Active neonatal seizures
• • Major congenital malformation
• • Parent does not provide written informed consent to participate in trial
• • Mother or neonate enrolled in another MRC/UVRI research project