Early Kangaroo Mother Care in Gambian Hospitalised Unstable Neonates

Death Clinical Trial

— eKMC  

Official title:

A Randomised Controlled Trial of Early Continuous Kangaroo Mother Care Versus Standard Care on Survival of Hospitalised Unstable Neonates <2000g in The Gambia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03555981
• Other study ID #: 14545
• Status: Terminated
• Phase: N/A
• Start date: May 20, 2018
• Est. completion date: April 20, 2020

Study information

• Verified date: July 2019
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The mortality effect of kangaroo mother care in stable newborns <2000g is well established but mortality effect in unstable newborns is not conclusively known. This pragmatic clinical trial aims to investigate the mortality and clinical effects of early continuous Kangaroo Mother Care (KMC) compared to standard care in mild-moderately unstable neonates <2000g in a resource limited hospital setting.

Description:

This individually randomised controlled trial will compare 2 parallel groups of hospitalised mild-moderately unstable neonates <2000g and aged <24h at time of screening who receive either early continuous kangaroo mother care (KMC) (started at <24h of admission) or standard care with continuous KMC at >24h of admission and when stable. The intervention will be un-blinded to participants and researchers with blinding of outcomes where possible. If participants clinically deteriorate and meet "stopping criteria" they will be temporarily withdrawn from the intervention arm and re-start KMC when clinically stable, as per the control arm. Intention to treat analysis will be used. Duration of time spent in KMC will be documented and compared between arms. All other hospital management will be provided as per a Standardised Preterm Management Protocol, based on current standard care at the study site and compliance to this protocol will be monitored in both arms.

Underlying protective mechanisms for early KMC will also be explored, focusing on causal pathways such as thermal control, cardio-respiratory stability, infection prevention control and gastro-intestinal stability pathways.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 279
• Est. completion date: April 20, 2020
• Est. primary completion date: April 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Hour to 24 Hours

Eligibility

Inclusion Criteria:

• New admission to study site during study period

• Admission weight <2000g

• Age 1 - 24h at start of screening

• Alive at enrolment

• Availability of study bed

• Written informed consent from parent or caregiver

• Parent or caregiver available and willing to provide intervention, if necessary

Exclusion Criteria:

• Congenital malformation incompatible with life or needing immediate surgical correction

• Severe jaundice needing immediate management

• Seizures

• Clinically stable as assessed over pre-defined period of cardio-respiratory monitoring

• Severely unstable as assessed over pre-defined period of cardio-respiratory monitoring

• Completed triplet admission

• Mother and/or neonate enrolled in another research study at time of hospital admission

Related Conditions & MeSH terms

• Bacterial Infections
• Death
• Hypothermia
• Hypothermia, Newborn
• Infection, Bacterial
• Kangaroo Mother Care
• Preterm Infant

Intervention

Other:
• Early Kangaroo Mother Care
Continuous skin-to-skin contact between baby and mother/caregiver started within 24h of hospital admission
• 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

Locations

Country	Name	City	State
Gambia	MRC Unit The Gambia at LSHTM	Fajara	Western Division

Sponsors (3)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Medical Research Council Unit, The Gambia, Wellcome Trust

Country where clinical trial is conducted

Gambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause Mortality	All neonatal deaths within 28 postnatal days	28 days
Secondary	Time to Death	Time from start of intervention/control procedures to death	28 days of age
Secondary	Cardio-respiratory Stability	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.	At 24 hours after start of intervention/control procedures
Secondary	Number and Proportion of Participants With Hypothermia	Number and proportion of participants with hypothermia (Temperature <36.5 degrees Celsius)	At 24 hours after start of intervention/control procedures
Secondary	Weight Gain	Average daily weight gain compared to admission weight	At 28 days of age
Secondary	Exclusive Breastfeeding	Number of babies who are exclusively breastfed (defined as only receiving breast milk with no infant formula supplementation)	At time of hospital discharge, within study period, on average 2 weeks of age
Secondary	Suspected Infection Between 3d to 28d of Age	Number and proportion of participants with suspected infection between 3d to 28d of age, or age at latest follow up	Within 28 days of age
Secondary	Neonatal Intestinal Carriage of Extended Spectrum Beta-Lactamase-producing Klebsiella Pneumoniae	Number and proportion of participants with intestinal carriage of Extended Spectrum Beta-Lactamase-Klebsiella pneumoniae	At day 28 of age
Secondary	Duration of Hospital Admission	Mean length of admission (first admission only if re-admitted)	Within 28 days of age or at latest follow-up