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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04036240
Enrollment
78
Registered
2019-07-29
Start date
2019-07-22
Completion date
2020-01-31
Last updated
2019-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Feeding, Low-Birth-Weight Infant

Keywords

low birth weight infant, breast milk supplementation, finger feeding

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.

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.

Interventions

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

Sponsors

Ludwig-Maximilians - University of Munich
CollaboratorOTHER
Fakultas Kedokteran Universitas Indonesia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Days to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Breastfeeding rate28 daysFormula used (ml/kg/day)

Secondary

MeasureTime frameDescription
Growth28 daysmean difference in weight, length, head circumference; skin fol thickness (mm)
Compliance28 daysNumber of supplementation per day
Stool consistencyup to 1 monthDiapered infant stool scale (1-5B)
Vomiting4 weeksnumber per day
Chokingup to 1 monthNumber per day
Infectionsup to 1 monthFever or other acute illness episode
Stool frequencyup to 1 monthNumber of stool per day

Other

MeasureTime frameDescription
Mothers's opinion about finger feeder supplementationup to 1 monthIn depth interview with guided questionnaire about using finger feeder at home (qualitative data)

Countries

Indonesia

Contacts

Primary ContactYoga Devaera, MD
yoga.devaera@ui.ac.id+628129431861
Backup ContactAryono Hendarto, PhD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026