Clinical trial NCT04036240: Finger Feeding as a Method of HMF Supplementation After Discharge
Official title: Finger Feeding as a Method of Human Milk Supplementation in Low Birth Weight Infants After Discharge: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low-Birth-Weight Infant
Breast Feeding
Keywords: low birth weight infant
breast milk supplementation
finger feeding
Lead sponsor: Fakultas Kedokteran Universitas Indonesia
Sponsor class: OTHER
Collaborators: name: Ludwig-Maximilians - University of Munich
First posted: 2019-07-29
Enrollment: 78
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Breastfeeding rate
timeFrame: 28 days
Secondary outcomes:
measure: Growth
timeFrame: 28 days
measure: Compliance
timeFrame: 28 days
measure: Stool consistency
timeFrame: up to 1 month
measure: Stool frequency
timeFrame: up to 1 month
measure: Vomiting
timeFrame: 4 weeks
measure: Choking
timeFrame: up to 1 month
measure: Infections
timeFrame: up to 1 month
Other outcomes:
measure: Mothers's opinion about finger feeder supplementation
timeFrame: up to 1 month
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Budi Kemuliaan Hospital
state: Jakarta
city: Bekasi
country: Indonesia
facility: RS Hermina Bekasi
state: Jawa Barat
city: Jakarta
country: Indonesia
facility: RS Hermina Jatinegara
city: Jakarta
country: Indonesia
facility: Koja District Hospital
Study officials:
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Yoga Devaera, MD
role: PRINCIPAL_INVESTIGATOR
References: