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

Sponsor
London School of Hygiene and Tropical Medicine (Other)
Overall Status
Recruiting
CT.gov ID
NCT02811432
Collaborator
MRC/UVRI and LSHTM Uganda Research Unit (Other), Makerere University (Other)
2,188
Enrollment
4
Locations
2
Arms
30.6
Anticipated Duration (Months)
547
Patients Per Site
17.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

We will conduct an individually randomised, controlled, superiority trial with two parallel groups; an intervention arm allocated to receive KMC and a control arm receiving 'standard' care. The primary aim is to examine the impact of KMC initiated before stabilisation on mortality within 7 days relative to standard care amongst neonates ≤2000g at four hospitals in Uganda. We hypothesise that neonates in the arm allocated to receive KMC before stabilisation will have a 25% overall reduction in mortality within 7 days compared to neonates allocated to receive standard care.

Condition or Disease Intervention/Treatment Phase
  • Other: Kangaroo mother care
  • Other: Standard care
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2188 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The OMWaNA Study: Operationalising Kangaroo Mother Care Before Stabilisation Amongst Low Birth Weight Neonates in Africa: a Multi-site Randomised Controlled Trial to Examine Mortality Impact in Uganda
Actual Study Start Date :
Jan 13, 2020
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Kangaroo mother care

Skin-to-skin care initiated as soon as possible following randomisation

Other: Kangaroo mother care
Skin-to-skin care (target: at least 18 hours per day)
Other Names:
  • Skin-to-skin care

    		•
    Active Comparator: Standard care

    Incubator or radiant warmer

    Other: Standard care
    Incubator or radiant warmer until neonate meets stability criteria; once stable (WHO indication for KMC certain), the baby can transition to routine (intermittent) KMC

    Outcome Measures

    Primary Outcome Measures

    1. Mortality within 7 days [7 days]

    Secondary Outcome Measures

    1. Prevalence of hypothermia at 24 hours post-randomisation [24 hours]

    2. Time from intervention/control procedures starting to clinical stabilisation [30 days]

    3. Time from intervention/control procedures starting to death [30 days]

    4. Mean duration of hospital admission [30 days]

    5. Proportion of neonates exclusively breastmilk feeding at discharge [30 days]

    6. Mortality within 28 days [28 days]

    7. Frequency of readmission [30 days]

    8. Daily weight gain at 28 days [28 days]

    9. Infant-caregiver attachment at 28 days [28 days]

    10. Women's well-being at 28 days [28 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Hour to 48 Hours
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Iganga District Hospital Iganga Uganda
    2 Jinja Regional Referral Hospital Jinja Uganda
    3 Kawempe National Referral Hospital Kampala Uganda
    4 Masaka Regional Referral Hospital Masaka Uganda

    Sponsors and Collaborators

    • London School of Hygiene and Tropical Medicine
    • MRC/UVRI and LSHTM Uganda Research Unit
    • Makerere University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    London School of Hygiene and Tropical Medicine
    ClinicalTrials.gov Identifier:
    NCT02811432
    Other Study ID Numbers:
    • 0
    First Posted:
    Jun 23, 2016
    Last Update Posted:
    Mar 15, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by London School of Hygiene and Tropical Medicine
    Kangaroo mother care
    Preterm infant
    Low birth weight
    Unstable
    Additional relevant MeSH terms:
    Hypothermia
    Birth Weight

    Study Results

    No Results Posted as of Mar 15, 2022