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

Preterm Infant Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02811432
• Other study ID #: 0
• Status: Completed
• Phase: N/A
• Start date: October 13, 2019
• Est. completion date: September 30, 2022

Study information

• Verified date: September 2023
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

METHODS Study setting, design, and participants The OMWaNA trial was an individually randomised, controlled, superiority trial with two parallel arms allocated in a 1:1 ratio to receive KMC initiated before stabilisation (intervention) or standard care (control). The trial was conducted in the neonatal units (WHO level-2) of five government hospitals in Uganda (appendix p 5). Infrastructure and equipment improvements as well as training were required prior to trial initiation, as described previously.10 All hospitals were provided with essential equipment and supplies to support the provision of KMC and level-2 newborn care. Details regarding study context and methods have been published in the trial protocol9 and are briefly summarised here. Ugandan practice is that maternity and newborn care should be provided free of charge in government health facilities;11 however, families are expected to support caregivers to meet essential needs such as meals.

The trial is reported here in accordance with the CONSORT guidelines. All live-born neonates, aged 1 to <48 hours and weighing 700-2000g, who were admitted to participating hospitals and for whom the indication for KMC was "uncertain" according to WHO guidance concerning clinical stability, defined as receiving ≥1 therapy (oxygen, continuous positive airway pressure [CPAP] where available, intravenous [IV] fluids, therapeutic antibiotics, anti-seizure medication), were eligible for inclusion. Exclusion criteria included triplet or higher multi-fetal pregnancy (unless pregnancy resulted in demise of ≥1 fetus) and parent/caregiver being unable/unwilling to provide either consent, KMC, and/or attend follow-up visits. Neonates with life-threatening instability, severe jaundice requiring immediate management, active seizures, or major congenital malformations were also excluded. The study was approved by the Research Ethics Committees of Uganda Virus Research Institute (GC/127/19/06/717), Uganda National Council of Science and Technology (HS 2645), and London School of Hygiene & Tropical Medicine (LSHTM, 16972). The trial was overseen by a steering committee and an independent data and safety monitoring board (DSMB).

Screening and informed consent All admitted neonates weighing ≤2000g were screened for eligibility by study staff. Stable neonates (meeting WHO 2019 criteria for KMC eligibility) were excluded and remaining neonates were assessed for eligibility. Those who met criteria for 'life-threatening instability' or who had conditions precluding KMC (e.g., seizures, jaundice), were reassessed every 3 hours up to 48 hours, after which they were excluded. Written informed parental consent was obtained for all participants.

Randomisation, allocation concealment and masking A random allocation sequence was computer-generated using permuted blocks of varying sizes stratified by birthweight (<1000g, 1000-1499g, ≥1500g) and recruitment site. Allocation concealment was done by programming the allocation sequence into the screening database and revealing treatment group only when screening of eligible neonates was complete. Neonates from multiple births (twins or triplets) were allocated to the same arm according to first-born allocation.14 Masking of parents, caregivers, or healthcare workers was not possible due to the nature of the KMC intervention.

Procedures In the intervention arm, KMC was initiated soon after randomisation. Neonates were naked except for hat and diaper, placed prone and skin-to-skin on caregiver's chest, and secured using a KMC wrap. Adjustable beds were provided to facilitate continuous skin-to-skin care. KMC duration was charted by caregivers and verified by study staff. When not in KMC (e.g., during maternal bathing), incubator or radiant heater care was commenced. Study personnel, in addition to hospital staff, provided continuous KMC counselling throughout the hospitalisation. Control arm neonates were cared for in an incubator or radiant heater, as per hospital practice. Caregivers could have physical contact with their newborn but skin-to-skin contact was not initiated until stability criteria were met.9 Once stable, newborns were transferred to routine (intermittent) KMC. Neonates in both arms received standard clinical care according to hospital guidelines.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2221
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Hour to 48 Hours

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Death; Neonatal
• Hypothermia
• Hypothermia, Newborn
• Kangaroo Mother Care
• Preterm Infant

Intervention

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

Locations

Country	Name	City	State
Uganda	Entebbe	Entebbe
Uganda	Iganga District Hospital	Iganga
Uganda	Jinja Regional Referral Hospital	Jinja
Uganda	Masaka Regional Referral Hospital	Masaka

Sponsors (3)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Makerere University, MRC/UVRI and LSHTM Uganda Research Unit

Country where clinical trial is conducted

Uganda, 

References & Publications (2)

Medvedev MM, Tumukunde V, Kirabo-Nagemi C, Greco G, Mambule I, Katumba K, Waiswa P, Tann CJ, Elbourne D, Allen E, Ekirapa-Kiracho E, Pitt C, Lawn JE. Process and costs for readiness to safely implement immediate kangaroo mother care: a mixed methods evaluation from the OMWaNA trial at five hospitals in Uganda. BMC Health Serv Res. 2023 Jun 10;23(1):613. doi: 10.1186/s12913-023-09624-z. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality within 7 days		7 days
Secondary	Prevalence of hypothermia at 24 hours post-randomisation		24 hours
Secondary	Time from intervention/control procedures starting to clinical stabilisation		30 days
Secondary	Time from intervention/control procedures starting to death		30 days
Secondary	Mean duration of hospital stay in days		30 days
Secondary	Proportion of neonates exclusively breastmilk feeding at discharge		30 days
Secondary	Mortality within 28 days		28 days
Secondary	Frequency of readmission		30 days
Secondary	Daily weight gain at 28 days		28 days
Secondary	Infant-caregiver attachment at 28 days		28 days
Secondary	Women's well-being at 28 days		28 days