Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2025-12-24 @ 9:38 PM
NCT ID:
NCT02811432
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Hour
Maximum Age:
48 Hours
Study:
NCT02811432
Study Brief:
Protocol Section:
NCT02811432