Finger Feeding as a Method of HMF Supplementation After Discharge

NCT04036240 | Unknown

• 1 other identifier: 2019-05-0711
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 4

Brief Summary

Human Milk Fortifier (HMF) is designed to supply additional calories, protein, vitamins and minerals to infants less than 37 weeks gestation or those less than 1500 g at birth. Liquid and powder types of HMF are available in the commercial market. Usually, one packet of powdered HMF is mixed to 25-50 cc expressed breast milk. Fortification of human milk is technically difficult in fully breastfed infants and artificial teats such as bottle feedings are common used. A study reported lower breastfeeding rate in intervention group who used HMF in comparison with control. Finger feeding method is associated with a better breastfeeding rate in hospital use. A feasibility study in Vienna reports finger feeding method as a way to provide fortification at home was acceptable.We hypothesize that finger feeding is an easy way for HMF supplementation after discharge to increase successful breastfeeding and improve growth in preterm and or low birth weight infants.

Conditions

Low-Birth-Weight Infant; Breast Feeding

Keywords

low birth weight infant; breast milk supplementation; finger feeding

Outcome Measures

Primary Outcomes (1)

• Breastfeeding rate

  Formula used (ml/kg/day)

  28 days

Secondary Outcomes (7)

• Growth

  28 days

• Compliance

  28 days

• Stool consistency

  up to 1 month

• Stool frequency

  up to 1 month

• Vomiting

  4 weeks

Other Outcomes (1)

• Mothers's opinion about finger feeder supplementation

  up to 1 month

Study Arms (2)

Finger feeder

EXPERIMENTAL

HMF supplementation will be given by finger feeder

Other: Finger feeding

Control

NO INTERVENTION

HMF supplementation will be given by mother preference such as cup, bottle.

Interventions

Finger feeding OTHER

After discharge, subjects will be given HMF supplementation by finger feeding method using finger feeder

Finger feeder

Eligibility Criteria

• Age: 3 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• birth weight \< 2500 g
• need HMF supplementation after discharge
• predominantly breastfed
• live in Jakarta city and its surrounding
• parents agree to follow study procedure with signed informed consent

You may not qualify if:

• major congenital anomaly or other conditions interfere with normal growth and oral feeding

Sponsors & Collaborators

• Fakultas Kedokteran Universitas Indonesia: lead
• Ludwig-Maximilians - University of Munich: collaborator

Study Sites (4)

Budi Kemuliaan Hospital

Jakarta Pusat, Jakarta Special Capital Region, 10110, Indonesia

RECRUITING

RS Hermina Bekasi

Bekasi, West Java, 17141, Indonesia

RECRUITING

RS Hermina Jatinegara

Jakarta, 13320, Indonesia

RECRUITING

Koja District Hospital

Jakarta, 14230, Indonesia

RECRUITING

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Yoga Devaera, MD

  Fakultas Kedokteran Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoga Devaera, MD

CONTACT

+628129431861; yoga.devaera@ui.ac.id

Aryono Hendarto, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Nutrition and Metabolic Diseases Division Dept of Child Health

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: July 29, 2019
• Study Start: July 22, 2019
• Primary Completion: December 30, 2019
• Study Completion: January 31, 2020
• Last Updated: December 27, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After publication
• Access Criteria: systematic review proposal

Locations

ID (4)