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

NCT ID: NCT06372418

Last Updated: 2024-04-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-31
• Study Completion Date: 2027-02-28

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.

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.

Conditions

Malnutrition, Infant; Breastfeeding, Exclusive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Breastfeeding peer support intervention

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Standard Care

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Standard Care

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

Intervention Type: OTHER

Eligibility Criteria

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.

-

• Minimum Eligible Age: 4 Weeks
• Maximum Eligible Age: 12 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martha Mwangome, PhD

Role: PRINCIPAL_INVESTIGATOR

KEMRI WELLCOME TRUST

Central Contacts

Fridah Munene

Role: CONTACT

fmunene@kemri-wellcome.org

+254 417 522 063

Grace Dena

Role: CONTACT

gdena@kemri-wellcome.org

+254 417 522 063

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Other Identifiers

KEMRI/SERU/CGMR-C/238/4326

Identifier Type: -

Identifier Source: org_study_id