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
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
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
NCT ID
NCT02811432
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
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
Learn more about this trial
Kangaroo Mother Care Before Stabilisation Amongst Low Birth Weight Neonates in Africa
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