Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Early Kangaroo Mother Care in Gambian Hospitalised Unstable Neonates (eKMC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03555981
Recruitment Status : Terminated (In response to COVID pandemic)
First Posted : June 14, 2018
Last Update Posted : May 14, 2020
Sponsor:
Collaborators:
Wellcome Trust
Medical Research Council Unit, The Gambia
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Preterm Infant Hypothermia, Newborn Death Kangaroo Mother Care Infection, Bacterial Other: Early Kangaroo Mother Care Other: Standard care Not Applicable

Detailed 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 If participants clinically deteriorate and meet "stopping criteria" they will be temporarily withdrawn from the intervention arm and re-start KMC when clinically stable, as per the control arm.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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 279 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Individually randomised controlled superiority trial
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 20, 2018
Actual Primary Completion Date : April 20, 2020
Actual Study Completion Date : April 20, 2020

Arm Intervention/treatment
Experimental: 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
Other: Early Kangaroo Mother Care
Continuous skin-to-skin contact between baby and mother/caregiver started within 24h of hospital admission
Other Names:
  • Early skin-to-skin contact
  • Early kangaroo method

Active Comparator: 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
Other: 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




Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 28 days ]
    All neonatal deaths


Secondary Outcome Measures :
  1. Time to death [ Time Frame: 28 days of age ]
    Time from start of intervention/control procedures to death

  2. Cardio-respiratory stability [ Time Frame: At 24 hours after start of intervention/control procedures ]
    Mean adjusted Stability of Cardio-Respiratory in Preterm (SCRIP) score

  3. Hypothermia [ Time Frame: At 24 hours after start of intervention/control procedures ]
    Prevalence of hypothermia (Temperature<36.5 degrees Celsius)

  4. Weight gain [ Time Frame: At 28 days of age ]
    Average daily weight gain compared to admission weight

  5. Exclusive breastfeeding [ Time Frame: At time of hospital discharge, within study period, on average 2 weeks of age ]
    Number of babies who are exclusively breastfed

  6. Suspected infection at >3 days of age (suspected late-onset infection) [ Time Frame: Within 28 days of age ]
    Incidence of clinically suspected infection at >3 days of age

  7. Neonatal intestinal carriage of Extended Spectrum Beta-Lactamase-producing Klebsiella pneumoniae [ Time Frame: At day 28 of age ]
    Prevalence of intestinal carriage of Extended Spectrum Beta-Lactamase-Klebsiella pneumoniae

  8. Duration of hospital admission [ Time Frame: Within 28 days of age or at latest follow-up ]
    Mean length of admission



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 24 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03555981


Locations
Layout table for location information
Gambia
MRC Unit The Gambia at LSHTM
Fajara, Western Division, Gambia
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Wellcome Trust
Medical Research Council Unit, The Gambia
Investigators
Layout table for investigator information
Principal Investigator: Helen C Brotherton, MBChB London School of Hygiene and Tropical Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT03555981    
Other Study ID Numbers: 14545
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Bacterial Infections
Hypothermia
Body Temperature Changes
Signs and Symptoms