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

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ClinicalTrials.gov Identifier: NCT02811432
Recruitment Status : Not yet recruiting
First Posted : June 23, 2016
Last Update Posted : August 1, 2019
Sponsor:
Collaborators:
MRC/UVRI and LSHTM Uganda Research Unit
Makerere University
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

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
Kangaroo Mother Care Preterm Infant Death; Neonatal Hypothermia, Newborn Other: Kangaroo mother care Other: Standard care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. Mortality within 7 days [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Prevalence of hypothermia at 24 hours post-randomisation [ Time Frame: 24 hours ]
  2. Time from intervention/control procedures starting to clinical stabilisation [ Time Frame: 30 days ]
  3. Time from intervention/control procedures starting to death [ Time Frame: 30 days ]
  4. Mean duration of hospital admission [ Time Frame: 30 days ]
  5. Proportion of neonates exclusively breastmilk feeding at discharge [ Time Frame: 30 days ]
  6. Mortality within 28 days [ Time Frame: 28 days ]
  7. Frequency of readmission [ Time Frame: 30 days ]
  8. Daily weight gain at 28 days [ Time Frame: 28 days ]
  9. Infant-caregiver attachment at 28 days [ Time Frame: 28 days ]
  10. Women's well-being at 28 days [ Time Frame: 28 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 48 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811432


Contacts
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Contact: Ruth Canter, MSc +44 (0)20 7927 2071 ruth.canter@lshtm.ac.uk
Contact: Melissa Medvedev (Morgan), MD, MSc melissa.morgan@lshtm.ac.uk

Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
MRC/UVRI and LSHTM Uganda Research Unit
Makerere University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT02811432    
Other Study ID Numbers: 0
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: LSHTM Data Compass

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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:
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Hypothermia
Birth Weight
Body Temperature Changes
Body Weight