Finger Feeding as a Method of HMF Supplementation After Discharge

Study Overview
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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.

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

Conditions
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Low-Birth-Weight Infant, Breast Feeding

Intervention / Treatment
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* Other: Finger feeding


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Finger feeder<br>HMF supplementation will be given by finger feeder | Other: Finger feeding<br>* After discharge, subjects will be given HMF supplementation by finger feeding method using finger feeder<br>|
| No Intervention: Control<br>HMF supplementation will be given by mother preference such as cup, bottle. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low birth weight infant, breast milk supplementation, finger feeding