Finger Feeding as a Method of HMF Supplementation After Discharge

Finger Feeding as a Method of Human Milk Supplementation in Low Birth Weight Infants After Discharge: a Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Breast Feeding; Low-Birth-Weight Infant
• Intervention / Treatment: Other: Finger feeding

Detailed Description

For infants with very low birth weight (<1500 g) convincing evidence indicates that providing multi-nutrients fortification including protein, long-chain polyunsaturated fatty acid, and micro-nutrients improves infant growth during hospitalization and health outcomes. A study of predominantly breastfed preterm infants with fortification after discharge shows better growth than unsupplemented counterparts at 3 months corrected age. Another study showed that post discharged growth of < 1800 g infants with human milk fortifier (HMF) supplementation until 48 weeks gestational age improved. But without the intensive lactation counselling the breast milk in HMF group were lower than control group if artificial teats were used. 4. Finger feeding is an alternative method to feed infants to increase successful breastfeeding, but unpopular in Indonesia. Study on finger feeding are still limited and most study of them are not randomized trial. We evaluate the method of supplementation on breastfeeding rate, growth and safety. We also do in depth interview with those who have high or low compliance.

• Study Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yoga Devaera, MD; Phone Number: +628129431861; Email: yoga.devaera@ui.ac.id
• Study Contact Backup: Name: Aryono Hendarto, PhD

Study Locations

• Indonesia
  • Jakarta, Indonesia, 13320
    • Recruiting
    • RS Hermina Jatinegara
    • Contact: Angeline Adrianne, MD; Phone Number: +6282177777611; Email: angeline.adrianne@icloud.com
    • Principal Investigator: Angeline Adrianne, MD
  • Jakarta, Indonesia, 14230
    • Recruiting
    • Koja District Hospital
    • Contact: Afaf Susilawati, MD; Email: susilawatiafaf@gmail.com
    • Principal Investigator: Afaf Susilawati, MD
  • Jakarta
    • Jakarta Pusat, Jakarta, Indonesia, 10110
      • Recruiting
      • Budi Kemuliaan Hospital
      • Contact: Irma Sapriani, MD
      • Contact: Yoga Devaera, MD
      • Principal Investigator: Irma Sapriani, MD
  • Jawa Barat
    • Bekasi, Jawa Barat, Indonesia, 17141
      • Recruiting
      • RS Hermina Bekasi
      • Contact: Elsa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 days and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Finger feeder; HMF supplementation will be given by finger feeder	Other: Finger feeding; After discharge, subjects will be given HMF supplementation by finger feeding method using finger feeder
NO_INTERVENTION: Control; HMF supplementation will be given by mother preference such as cup, bottle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breastfeeding rate	Formula used (ml/kg/day)	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Growth	mean difference in weight, length, head circumference; skin fol thickness (mm)	28 days
Compliance	Number of supplementation per day	28 days
Stool consistency	Diapered infant stool scale (1-5B)	up to 1 month
Stool frequency	Number of stool per day	up to 1 month
Vomiting	number per day	4 weeks
Choking	Number per day	up to 1 month
Infections	Fever or other acute illness episode	up to 1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mothers's opinion about finger feeder supplementation	In depth interview with guided questionnaire about using finger feeder at home (qualitative data)	up to 1 month

Collaborators and Investigators

• Sponsor: Fakultas Kedokteran Universitas Indonesia
• Collaborators: Ludwig-Maximilians - University of Munich
• Investigators: Principal Investigator: Yoga Devaera, MD, Fakultas Kedokteran Universitas Indonesia

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 22, 2019
• Primary Completion (ANTICIPATED): December 30, 2019
• Study Completion (ANTICIPATED): January 31, 2020

Study Registration Dates

• First Submitted: July 22, 2019
• First Submitted That Met QC Criteria: July 26, 2019
• First Posted (ACTUAL): July 29, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 27, 2019
• Last Update Submitted That Met QC Criteria: December 24, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: low birth weight infant; breast milk supplementation; finger feeding
• Additional Relevant MeSH Terms: Body Weight; Birth Weight
• Other Study ID Numbers: 2019-05-0711

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD in results after publication
• IPD Sharing Time Frame: After publication
• IPD Sharing Access Criteria: systematic review proposal
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No