Providing Breastfeeding Support After Discharge From Hospital to Improve Growth and Development of Malnourished Infants

NCT06372418 | Not Yet Recruiting

• 1 other identifier: KEMRI/SERU/CGMR-C/238/4326
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Malnutrition, Infant; Breastfeeding, Exclusive

Outcome Measures

Primary Outcomes (1)

• Weight gain

  The primary outcome for the trial is growth (weight gain) assessed at 26 weeks of age

  At 26 weeks of age

Secondary Outcomes (2)

• Morbidity

  At 39 weeks and 52 weeks of age

• Mortality

  At 39 to 52 weeks of age

Study Arms (2)

Breastfeeding peer support intervention.

EXPERIMENTAL

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

Standard of care

ACTIVE COMPARATOR

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

Interventions

Breastfeeding peer support intervention OTHER

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.

Breastfeeding peer support intervention.

Standard Care OTHER

Caregivers will receive post-discharge support as currently recommended by the World Health Organization (WHO) and national IMAM guidelines.

Standard of care

Eligibility Criteria

• Age: 4 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oxford: lead

Related Publications (30)

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MeSH Terms

Conditions

Infant Nutrition Disorders; Breast Feeding

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Martha Mwangome, PhD

  KEMRI WELLCOME TRUST

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fridah Munene

CONTACT

+254 417 522 063; fmunene@kemri-wellcome.org

Grace Dena

CONTACT

+254 417 522 063; gdena@kemri-wellcome.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Fieldworkers collecting endpoint data at 6 months of age will be blinded to group allocation to avoid any bias subject to knowledge of group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Control Trial: Participants will be randomized to either receive Breastfeeding support intervention (BFSI) or standard of care.

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: April 18, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 3 years
• Access Criteria: Apply to the Data Governance Committee: dgc@kemri-wellcome.org