Trial Outcomes & Findings for Early Kangaroo Mother Care in Gambian Hospitalised Unstable Neonates (NCT NCT03555981)

Results Overview

All neonatal deaths within 28 postnatal days

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

279 participants

Primary outcome timeframe

28 days

Results posted on

2026-04-16

Participant Flow

Recruitment took place from 23rd May 2018 - 19th March 2020 at the neonatal unit of the only teaching hospital in The Gambia, providing WHO level 2+ newborn care.

Participant milestones

Participant milestones
Measure	Early KMC Continuous kangaroo mother care started within 24h of hospital admission, aiming for minimum 18h/day and until hospital discharge with encouragement of KMC at home Early Kangaroo Mother Care: Continuous skin-to-skin contact between baby and mother/caregiver started within 24h of hospital admission	Standard Care Standard care under radiant heater or incubator until clinical stability criteria are met then intermittent or continuous Kangaroo mother care started at \>24h of hospital admission until hospital discharge with encouragement of KMC at home Standard care: Incubator or radiant heater care until stable, off oxygen and \>24h of admission, at which point will start intermittent or continuous kangaroo mother care
Overall Study STARTED	138	141
Overall Study COMPLETED	138	139
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Early KMC Continuous kangaroo mother care started within 24h of hospital admission, aiming for minimum 18h/day and until hospital discharge with encouragement of KMC at home Early Kangaroo Mother Care: Continuous skin-to-skin contact between baby and mother/caregiver started within 24h of hospital admission	Standard Care Standard care under radiant heater or incubator until clinical stability criteria are met then intermittent or continuous Kangaroo mother care started at \>24h of hospital admission until hospital discharge with encouragement of KMC at home Standard care: Incubator or radiant heater care until stable, off oxygen and \>24h of admission, at which point will start intermittent or continuous kangaroo mother care
Overall Study Lost to Follow-up	0	2

Baseline Characteristics

Gestational age data available for only 271 due to death before assessment in 8 participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Early KMC n=138 Participants Continuous kangaroo mother care started within 24h of hospital admission, aiming for minimum 18h/day and until hospital discharge with encouragement of KMC at home Early Kangaroo Mother Care: Continuous skin-to-skin contact between baby and mother/caregiver started within 24h of hospital admission	Standard Care n=141 Participants Standard care under radiant heater or incubator until clinical stability criteria are met then intermittent or continuous Kangaroo mother care started at \>24h of hospital admission until hospital discharge with encouragement of KMC at home Standard care: Incubator or radiant heater care until stable, off oxygen and \>24h of admission, at which point will start intermittent or continuous kangaroo mother care	Total n=279 Participants Total of all reporting groups
Age, Categorical <=18 years	138 Participants n=138 Participants	141 Participants n=141 Participants	279 Participants n=279 Participants
Age, Categorical Between 18 and 65 years	NA Participants n=138 Participants	NA Participants n=141 Participants	NA Participants n=279 Participants
Age, Categorical >=65 years	NA Participants n=138 Participants	NA Participants n=141 Participants	NA Participants n=279 Participants
Age, Continuous	2.3 hours n=138 Participants	2.3 hours n=141 Participants	2.3 hours n=279 Participants
Sex: Female, Male Female	79 Participants n=138 Participants	82 Participants n=141 Participants	161 Participants n=279 Participants
Sex: Female, Male Male	59 Participants n=138 Participants	59 Participants n=141 Participants	118 Participants n=279 Participants
Race/Ethnicity, Customized Gambian	138 Participants n=138 Participants	141 Participants n=141 Participants	279 Participants n=279 Participants
Region of Enrollment Gambia	138 participants n=138 Participants	141 participants n=141 Participants	279 participants n=279 Participants
Admission weight	1459 grams n=138 Participants	1436 grams n=141 Participants	1450 grams n=279 Participants
Admission weight <1200g	34 Participants n=138 Participants	39 Participants n=141 Participants	73 Participants n=279 Participants
Gestational age	33 weeks n=136 Participants • Gestational age data available for only 271 due to death before assessment in 8 participants	32 weeks n=135 Participants • Gestational age data available for only 271 due to death before assessment in 8 participants	33 weeks n=271 Participants • Gestational age data available for only 271 due to death before assessment in 8 participants
Twin pregnancy	41 Participants n=138 Participants	45 Participants n=141 Participants	86 Participants n=279 Participants
Twin, both enrolled	24 Participants n=138 Participants	24 Participants n=141 Participants	48 Participants n=279 Participants
Stable at baseline	14 Participants n=138 Participants	5 Participants n=141 Participants	19 Participants n=279 Participants

PRIMARY outcome

Timeframe: 28 days

Population: All recruited neonates with primary outcome data at 28 days were included in the analysis. This consisted of all (n=138) neonates allocated to the intervention arm and 139 neonates in the control arm, as two control participants were lost to follow up.

All neonatal deaths within 28 postnatal days

Outcome measures

Outcome measures
Measure	Early KMC n=138 Participants Continuous kangaroo mother care started within 24h of hospital admission, aiming for minimum 18h/day and until hospital discharge with encouragement of KMC at home Early Kangaroo Mother Care: Continuous skin-to-skin contact between baby and mother/caregiver started within 24h of hospital admission	Standard Care n=139 Participants Standard care under radiant heater or incubator until clinical stability criteria are met then intermittent or continuous Kangaroo mother care started at \>24h of hospital admission until hospital discharge with encouragement of KMC at home Standard care: Incubator or radiant heater care until stable, off oxygen and \>24h of admission, at which point will start intermittent or continuous kangaroo mother care
All-cause Mortality	29 Participants	34 Participants

SECONDARY outcome

Timeframe: 28 days of age

Time from start of intervention/control procedures to death

Outcome measures

Outcome measures
Measure	Early KMC n=29 Participants Continuous kangaroo mother care started within 24h of hospital admission, aiming for minimum 18h/day and until hospital discharge with encouragement of KMC at home Early Kangaroo Mother Care: Continuous skin-to-skin contact between baby and mother/caregiver started within 24h of hospital admission	Standard Care n=34 Participants Standard care under radiant heater or incubator until clinical stability criteria are met then intermittent or continuous Kangaroo mother care started at \>24h of hospital admission until hospital discharge with encouragement of KMC at home Standard care: Incubator or radiant heater care until stable, off oxygen and \>24h of admission, at which point will start intermittent or continuous kangaroo mother care
Time to Death	90.0 hours Interval 65.0 to 172.0	98.5 hours Interval 29.0 to 132.0

SECONDARY outcome

Timeframe: At 24 hours after start of intervention/control procedures

Population: Only neonates with outcome data available at 24h after enrolment were included in the analysis, hence the number of participants analysed is less than 279. This was principally due to mortality during first 24h of trial.

The 'Stability of Cardio-Respiratory in Preterm' infants is a scale to quantify the cardio-respiratory stability of preterm infants. It is composed of three parameters: Heart rate; Respiratory rate and breathing pattern and oxygen saturation (including whether is in oxygen). Scores between 0 and 2 are allocated for each parameter, with minimum total score 0 and maximum total score 6. The highest score (6) represents a better outcome, with all parameters within normal range whilst not receiving oxygen.

Outcome measures

Outcome measures
Measure	Early KMC n=134 Participants Continuous kangaroo mother care started within 24h of hospital admission, aiming for minimum 18h/day and until hospital discharge with encouragement of KMC at home Early Kangaroo Mother Care: Continuous skin-to-skin contact between baby and mother/caregiver started within 24h of hospital admission	Standard Care n=135 Participants Standard care under radiant heater or incubator until clinical stability criteria are met then intermittent or continuous Kangaroo mother care started at \>24h of hospital admission until hospital discharge with encouragement of KMC at home Standard care: Incubator or radiant heater care until stable, off oxygen and \>24h of admission, at which point will start intermittent or continuous kangaroo mother care
Cardio-respiratory Stability	5 units on a scale Interval 4.0 to 5.0	5 units on a scale Interval 4.0 to 6.0

SECONDARY outcome

Timeframe: At 24 hours after start of intervention/control procedures

Population: Only neonates with outcome data available at 24h after enrolment were included in the analysis, hence the number of participants analysed is less than 279. This was principally due to mortality during first 24h of trial.

Number and proportion of participants with hypothermia (Temperature \<36.5 degrees Celsius)

Outcome measures

Outcome measures
Measure	Early KMC n=134 Participants Continuous kangaroo mother care started within 24h of hospital admission, aiming for minimum 18h/day and until hospital discharge with encouragement of KMC at home Early Kangaroo Mother Care: Continuous skin-to-skin contact between baby and mother/caregiver started within 24h of hospital admission	Standard Care n=135 Participants Standard care under radiant heater or incubator until clinical stability criteria are met then intermittent or continuous Kangaroo mother care started at \>24h of hospital admission until hospital discharge with encouragement of KMC at home Standard care: Incubator or radiant heater care until stable, off oxygen and \>24h of admission, at which point will start intermittent or continuous kangaroo mother care
Number and Proportion of Participants With Hypothermia	51 Participants	55 Participants

SECONDARY outcome

Timeframe: At 28 days of age

Population: Only neonates with outcome data available at age 28d were included in the analysis, hence the number of participants analysed is less than 279. This was principally due to mortality, loss to follow up and small number of participants with missing data

Average daily weight gain compared to admission weight

Outcome measures

Outcome measures
Measure	Early KMC n=103 Participants Continuous kangaroo mother care started within 24h of hospital admission, aiming for minimum 18h/day and until hospital discharge with encouragement of KMC at home Early Kangaroo Mother Care: Continuous skin-to-skin contact between baby and mother/caregiver started within 24h of hospital admission	Standard Care n=101 Participants Standard care under radiant heater or incubator until clinical stability criteria are met then intermittent or continuous Kangaroo mother care started at \>24h of hospital admission until hospital discharge with encouragement of KMC at home Standard care: Incubator or radiant heater care until stable, off oxygen and \>24h of admission, at which point will start intermittent or continuous kangaroo mother care
Weight Gain	10.3 grams/day Standard Deviation 10.1	12.5 grams/day Standard Deviation 12.1

SECONDARY outcome

Timeframe: At time of hospital discharge, within study period, on average 2 weeks of age

Population: Only neonates with outcome data available at discharge were included in the analysis, hence the number of participants analysed is less than 279. The missing data was principally due to mortality prior to discharge.

Number of babies who are exclusively breastfed (defined as only receiving breast milk with no infant formula supplementation)

Outcome measures

Outcome measures
Measure	Early KMC n=109 Participants Continuous kangaroo mother care started within 24h of hospital admission, aiming for minimum 18h/day and until hospital discharge with encouragement of KMC at home Early Kangaroo Mother Care: Continuous skin-to-skin contact between baby and mother/caregiver started within 24h of hospital admission	Standard Care n=107 Participants Standard care under radiant heater or incubator until clinical stability criteria are met then intermittent or continuous Kangaroo mother care started at \>24h of hospital admission until hospital discharge with encouragement of KMC at home Standard care: Incubator or radiant heater care until stable, off oxygen and \>24h of admission, at which point will start intermittent or continuous kangaroo mother care
Exclusive Breastfeeding	107 Participants	105 Participants

SECONDARY outcome

Timeframe: Within 28 days of age

Population: All randomised participants were included in the analysis

Number and proportion of participants with suspected infection between 3d to 28d of age, or age at latest follow up

Outcome measures

Outcome measures
Measure	Early KMC n=138 Participants Continuous kangaroo mother care started within 24h of hospital admission, aiming for minimum 18h/day and until hospital discharge with encouragement of KMC at home Early Kangaroo Mother Care: Continuous skin-to-skin contact between baby and mother/caregiver started within 24h of hospital admission	Standard Care n=141 Participants Standard care under radiant heater or incubator until clinical stability criteria are met then intermittent or continuous Kangaroo mother care started at \>24h of hospital admission until hospital discharge with encouragement of KMC at home Standard care: Incubator or radiant heater care until stable, off oxygen and \>24h of admission, at which point will start intermittent or continuous kangaroo mother care
Suspected Infection Between 3d to 28d of Age	28 Participants	21 Participants

SECONDARY outcome

Timeframe: At day 28 of age

Number and proportion of participants with intestinal carriage of Extended Spectrum Beta-Lactamase-Klebsiella pneumoniae

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within 28 days of age or at latest follow-up

Population: Only neonates with outcome data available at time of discharge were included in the analysis, hence the number of participants analysed is less than 279. Neonates were died during first hospital admission were not included in the analysis.

Mean length of admission (first admission only if re-admitted)

Outcome measures

Outcome measures
Measure	Early KMC n=103 Participants Continuous kangaroo mother care started within 24h of hospital admission, aiming for minimum 18h/day and until hospital discharge with encouragement of KMC at home Early Kangaroo Mother Care: Continuous skin-to-skin contact between baby and mother/caregiver started within 24h of hospital admission	Standard Care n=101 Participants Standard care under radiant heater or incubator until clinical stability criteria are met then intermittent or continuous Kangaroo mother care started at \>24h of hospital admission until hospital discharge with encouragement of KMC at home Standard care: Incubator or radiant heater care until stable, off oxygen and \>24h of admission, at which point will start intermittent or continuous kangaroo mother care
Duration of Hospital Admission	16.6 Days Standard Deviation 11.1	16.3 Days Standard Deviation 10.0

Adverse Events

Early KMC

Serious events: 30 serious events

Other events: 0 other events

Deaths: 29 deaths

Standard Care

Serious events: 28 serious events

Other events: 0 other events

Deaths: 34 deaths

Serious adverse events

Serious adverse events
Measure	Early KMC n=138 participants at risk Continuous kangaroo mother care started within 24h of hospital admission, aiming for minimum 18h/day and until hospital discharge with encouragement of KMC at home Early Kangaroo Mother Care: Continuous skin-to-skin contact between baby and mother/caregiver started within 24h of hospital admission	Standard Care n=141 participants at risk Standard care under radiant heater or incubator until clinical stability criteria are met then intermittent or continuous Kangaroo mother care started at \>24h of hospital admission until hospital discharge with encouragement of KMC at home Standard care: Incubator or radiant heater care until stable, off oxygen and \>24h of admission, at which point will start intermittent or continuous kangaroo mother care
General disorders Life threatening event	9.4% 13/138 • Number of events 13 • 28 postnatal days Only serious adverse events were monitored/assessed. Other adverse events were not monitored/assessed.	7.8% 11/141 • Number of events 11 • 28 postnatal days Only serious adverse events were monitored/assessed. Other adverse events were not monitored/assessed.
Nervous system disorders Risk of disability	4.3% 6/138 • Number of events 6 • 28 postnatal days Only serious adverse events were monitored/assessed. Other adverse events were not monitored/assessed.	5.0% 7/141 • Number of events 7 • 28 postnatal days Only serious adverse events were monitored/assessed. Other adverse events were not monitored/assessed.
General disorders Hospital re-admission	2.9% 4/138 • Number of events 4 • 28 postnatal days Only serious adverse events were monitored/assessed. Other adverse events were not monitored/assessed.	3.5% 5/141 • Number of events 5 • 28 postnatal days Only serious adverse events were monitored/assessed. Other adverse events were not monitored/assessed.
General disorders Prolonged hospitalisation	5.1% 7/138 • Number of events 7 • 28 postnatal days Only serious adverse events were monitored/assessed. Other adverse events were not monitored/assessed.	3.5% 5/141 • Number of events 5 • 28 postnatal days Only serious adverse events were monitored/assessed. Other adverse events were not monitored/assessed.

Other adverse events

Adverse event data not reported

Additional Information

Dr Helen Brotherton

London School of Hygiene & Tropical Medicine

Phone: 07481474150

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place