Providing Breastfeeding Support After Discharge From Hospital to Improve Growth and Development of Malnourished Infants (IBAMI-2)

April 17, 2024 updated by: University of Oxford

Enhancing Growth and Development Among Malnourished Infants Recovering From a Serious Illness (IBAMI-2)

The current guidelines used to manage malnutrition among infants aged below 6 months (u6m) recommend that infants admitted to hospital with malnutrition be supported to reestablish exclusive breastfeeding before discharge. Studies have shown that reestablishing exclusive breastfeeding among infants being treated for acute malnutrition is possible. However, follow-up of the infants after discharge has revealed poor growth raising questions about what happens to infant feeding practices after discharge and whether providing breastfeeding support to mothers after discharge would help improve the recovery and growth of their infants.

Providing a package of home-based care with breastfeeding support to mothers of infants u6m recovering from acute malnutrition has the potential to improve the retention of exclusive breastfeeding and lead to enhanced infant growth and survival. To date, no such post-discharge package of care is available in Kenya or other lower and meddle income countries (LMICs). The aim of this study is to apply participatory, qualitative and quantitative approaches to develop and evaluate the impact of a post-discharge package of care on the growth and development of acutely ill malnourished infants after discharge from hospital.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Globally, acute malnutrition affects 8.5 million infants under 6 months of age (u6m). These malnourished infants u6m are at elevated risk of death during admission, death after discharge from hospital and subsequent neurodevelopmental impairment. The 2020 national guidelines for integrated management of acute malnutrition for infants and children (IMAM) recommend that for hospitalised malnourished infants u6m the treatment should focus on re-establishing exclusive breastfeeding (EBF) with discharge when consistent weight gain of >20g/day is achieved on breastmilk alone. In Kilifi, a study to investigate the outcomes of effective guideline implementation, employed breastfeeding peer supporters to facilitate re-establishing exclusive breastfeeding among sick hospitalized malnourished infants u6m.The study achieved 81% infants exclusive breastfeeding by discharge with 67% attaining the World health organization recommended growth velocity on breastmilk alone. However, when infants were followed up 6 weeks after discharge, the criteria for full nutritional recovery, weight adjusted for Length Z score (WFL)>2 were generally not met. Interviews with mothers, breastfeeding peer supporters (BFPS) and health workers at discharge and 4 weeks after discharge suggested that BFPS were central in enabling mothers to achieve exclusive breastfeeding but that mothers found it challenging to maintain exclusive breastfeeding at home after discharge without on-going support. This follow-on study will investigate the hypothesis that providing support during transition from hospital to home environment will help improve nutritional recovery among this vulnerable group of infants. The study will take part in two phases. Phase1 will use participatory and qualitative approaches to develop and pilot test a post-discharge breast-feeding support intervention (BFSI). Phase 2 will involve a randomized control trial to measure the impact of the intervention on growth, EBF and neurodevelopmental outcomes of malnourished infants discharged from hospital following a serious illness.

The primary outcome for the trial is growth (weight gain) assessed at age 6 months, with additional follow up at 9 and 12 months of age to assess mortality, morbidity and neurodevelopmental outcomes. The results of the study will inform efforts to improve post-discharge management of recovering malnourished vulnerable infants u6m.

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Infants admitted to Kilifi County Hospital (KCH) aged between 4 weeks and 12 weeks old

AND Wasting or underweight assessed by Weight-for-length Z-score (WFLz)<-2 OR Weight-for-age Z-score (WFAz) <-2

OR Mid upper arm circumference (MUAC)<110mm OR presence of bilateral pitting oedema AND

  • Any possibility to breastfeed (carer of reproductive age willing to breastfeed and infant without clinical abnormalities obstructing breastfeeding
  • Caregivers consent to participation in the study

Exclusion Criteria:

Infants with no possibility to breastfeed. OR Infants with congenital abnormalities that would affect breastfeeding e.g. cleft palate or invalidate the use of normal growth standards.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Breastfeeding peer support intervention.
In addition to support as currently recommended by the World Health Organization (WHO) and National IMAM guidelines, the intervention arm will receive a homebased individualized face to face support breastfeeding by peer supporters and phone support for 7 weeks post hospital discharge.
Other: Breastfeeding peer support intervention
In addition to support as currently recommended by the World Health Organization (WHO) and National IMAM guidelines, care givers will receive a homebased individualized face to face support provided by breastfeeding peer supporters and phone call support upto 7 weeks post hospital discharge.
Active Comparator: Standard of care
The Control arm will receive post-discharge support as currently recommended by the World Health Organization (WHO) and national IMAM guidelines, including providing linkage to available local breastfeeding support groups.
Other: Standard Care
Caregivers will receive post-discharge support as currently recommended by the World Health Organization (WHO) and national IMAM guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight gain
Time Frame: At 26 weeks of age
The primary outcome for the trial is growth (weight gain) assessed at 26 weeks of age
At 26 weeks of age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbidity
Time Frame: At 39 weeks and 52 weeks of age
Assess morbidity at 39 weeks and 52 weeks of age
At 39 weeks and 52 weeks of age
Mortality
Time Frame: At 39 to 52 weeks of age
To assess for mortality at the age of 39 to 52 weeks of age
At 39 to 52 weeks of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Investigators

  • Principal Investigator: Martha Mwangome, PhD, KEMRI WELLCOME TRUST

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

July 10, 2023

First Submitted That Met QC Criteria

April 17, 2024

First Posted (Actual)

April 18, 2024

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEMRI/SERU/CGMR-C/238/4326

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Summary information concerning the study will be posted on the https://clinicaltrials.gov/ platform and on Kenya Medical research Institution (KEMRI)/Wellcome Trust Research Programmes website. Data hosted on the Kemri-Wellcome Trust Research Program (KWTRP) Research Data Repository (https://dataverse.harvard.edu/dataverse/kwtrp will be issued with a Digital Object Identifier (DOI). This can be included as part of a data citation in publications, allowing the datasets underpinning a publication to be identified and accessed. Metadata and documentation about datasets held in KWTRP Data Repository will be publicly searchable and discoverable. Access to the archived data will be managed by the Data Governance committee which receives and reviews requests for both internal and external data sharing.

IPD Sharing Time Frame

3 years

IPD Sharing Access Criteria

Apply to the Data Governance Committee: dgc@kemri-wellcome.org

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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