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Finger Feeding as a Method of HMF Supplementation After Discharge

NCT ID: NCT04036240

Last Updated: 2019-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-22

Study Completion Date

2020-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Low-Birth-Weight Infant Breast Feeding

Keywords

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low birth weight infant breast milk supplementation finger feeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Finger feeder

HMF supplementation will be given by finger feeder

Group Type EXPERIMENTAL

Finger feeding

Intervention Type OTHER

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

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Finger feeding

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

3 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role collaborator

Fakultas Kedokteran Universitas Indonesia

OTHER

Sponsor Role lead

Responsible Party

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YogaD

Head of Nutrition and Metabolic Diseases Division Dept of Child Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yoga Devaera, MD

Role: PRINCIPAL_INVESTIGATOR

Fakultas Kedokteran Universitas Indonesia

Locations

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Budi Kemuliaan Hospital

Jakarta Pusat, Jakarta Special Capital Region, Indonesia

Site Status RECRUITING

RS Hermina Bekasi

Bekasi, West Java, Indonesia

Site Status RECRUITING

RS Hermina Jatinegara

Jakarta, , Indonesia

Site Status RECRUITING

Koja District Hospital

Jakarta, , Indonesia

Site Status RECRUITING

Countries

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Indonesia

Central Contacts

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Yoga Devaera, MD

Role: CONTACT

Phone: +628129431861

Email: [email protected]

Aryono Hendarto, PhD

Role: CONTACT

Facility Contacts

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Irma Sapriani, MD

Role: primary

Yoga Devaera, MD

Role: backup

Elsa

Role: primary

Angeline Adrianne, MD

Role: primary

Afaf Susilawati, MD

Role: primary

Other Identifiers

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2019-05-0711

Identifier Type: -

Identifier Source: org_study_id