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

Primary Purpose

Kangaroo Mother Care, Preterm Infant, Death; Neonatal

Status
Recruiting
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Kangaroo mother care
Standard care
Sponsored by
London School of Hygiene and Tropical Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kangaroo Mother Care focused on measuring Kangaroo mother care, Preterm infant, Low birth weight, Unstable

Eligibility Criteria

1 Hour - 48 Hours (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Iganga District HospitalRecruiting
  • Jinja Regional Referral HospitalRecruiting
  • Kawempe National Referral HospitalRecruiting
  • Masaka Regional Referral HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Kangaroo mother care

Standard care

Arm Description

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

Incubator or radiant warmer

Outcomes

Primary Outcome Measures

Mortality within 7 days

Secondary Outcome Measures

Prevalence of hypothermia at 24 hours post-randomisation
Time from intervention/control procedures starting to clinical stabilisation
Time from intervention/control procedures starting to death
Mean duration of hospital admission
Proportion of neonates exclusively breastmilk feeding at discharge
Mortality within 28 days
Frequency of readmission
Daily weight gain at 28 days
Infant-caregiver attachment at 28 days
Women's well-being at 28 days

Full Information

First Posted
June 21, 2016
Last Updated
February 28, 2022
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
MRC/UVRI and LSHTM Uganda Research Unit, Makerere University
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1. Study Identification

Unique Protocol Identification Number
NCT02811432
Brief Title
Kangaroo Mother Care Before Stabilisation Amongst Low Birth Weight Neonates in Africa
Acronym
OMWaNA
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 13, 2020 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
MRC/UVRI and LSHTM Uganda Research Unit, Makerere University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kangaroo Mother Care, Preterm Infant, Death; Neonatal, Hypothermia, Newborn
Keywords
Kangaroo mother care, Preterm infant, Low birth weight, Unstable

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2188 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Kangaroo mother care
Arm Type
Experimental
Arm Description
Skin-to-skin care initiated as soon as possible following randomisation
Arm Title
Standard care
Arm Type
Active Comparator
Arm Description
Incubator or radiant warmer
Intervention Type
Other
Intervention Name(s)
Kangaroo mother care
Other Intervention Name(s)
Skin-to-skin care
Intervention Description
Skin-to-skin care (target: at least 18 hours per day)
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
Incubator or radiant warmer until neonate meets stability criteria; once stable (WHO indication for KMC certain), the baby can transition to routine (intermittent) KMC
Primary Outcome Measure Information:
Title
Mortality within 7 days
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Prevalence of hypothermia at 24 hours post-randomisation
Time Frame
24 hours
Title
Time from intervention/control procedures starting to clinical stabilisation
Time Frame
30 days
Title
Time from intervention/control procedures starting to death
Time Frame
30 days
Title
Mean duration of hospital admission
Time Frame
30 days
Title
Proportion of neonates exclusively breastmilk feeding at discharge
Time Frame
30 days
Title
Mortality within 28 days
Time Frame
28 days
Title
Frequency of readmission
Time Frame
30 days
Title
Daily weight gain at 28 days
Time Frame
28 days
Title
Infant-caregiver attachment at 28 days
Time Frame
28 days
Title
Women's well-being at 28 days
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
48 Hours
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruth Canter, MSc
Phone
+44 (0)20 7927 2071
Email
ruth.canter@lshtm.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Melissa Medvedev (Morgan), MD, MSc
Email
melissa.morgan@lshtm.ac.uk
Facility Information:
Facility Name
Iganga District Hospital
City
Iganga
Country
Uganda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Mambule
Email
ivan.mambule@mrcuganda.org
Facility Name
Jinja Regional Referral Hospital
City
Jinja
Country
Uganda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Mambule
Email
ivan.mambule@mrcuganda.org
Facility Name
Kawempe National Referral Hospital
City
Kampala
Country
Uganda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Mambule
Email
ivan.mambule@mrcuganda.org
Facility Name
Masaka Regional Referral Hospital
City
Masaka
Country
Uganda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Mambule
Email
ivan.mambule@mrcuganda.org

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
LSHTM Data Compass
Citations:
PubMed Identifier
32005286
Citation
Medvedev MM, Tumukunde V, Mambule I, Tann CJ, Waiswa P, Canter RR, Hansen CH, Ekirapa-Kiracho E, Katumba K, Pitt C, Greco G, Brotherton H, Elbourne D, Seeley J, Nyirenda M, Allen E, Lawn JE. Operationalising kangaroo Mother care before stabilisation amongst low birth Weight Neonates in Africa (OMWaNA): protocol for a randomised controlled trial to examine mortality impact in Uganda. Trials. 2020 Jan 31;21(1):126. doi: 10.1186/s13063-019-4044-6.
Results Reference
derived

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

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