Finger Feeding as a Method of HMF Supplementation After Discharge

Breast Feeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04036240
• Other study ID #: 2019-05-0711
• Status: Recruiting
• Phase: N/A
• Start date: July 22, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: December 2019
• Source: Fakultas Kedokteran Universitas Indonesia
• Contact: Yoga Devaera, MD
• Phone: +628129431861
• Email: yoga.devaera[@]ui.ac.id
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: January 31, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Breast Feeding
• Low-Birth-Weight Infant

Intervention

Other:
• Finger feeding
After discharge, subjects will be given HMF supplementation by finger feeding method using finger feeder

Locations

Country	Name	City	State
Indonesia	RS Hermina Bekasi	Bekasi	Jawa Barat
Indonesia	Koja District Hospital	Jakarta
Indonesia	RS Hermina Jatinegara	Jakarta
Indonesia	Budi Kemuliaan Hospital	Jakarta Pusat	Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
Fakultas Kedokteran Universitas Indonesia	Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Breastfeeding rate	Formula used (ml/kg/day)	28 days
Secondary	Growth	mean difference in weight, length, head circumference; skin fol thickness (mm)	28 days
Secondary	Compliance	Number of supplementation per day	28 days
Secondary	Stool consistency	Diapered infant stool scale (1-5B)	up to 1 month
Secondary	Stool frequency	Number of stool per day	up to 1 month
Secondary	Vomiting	number per day	4 weeks
Secondary	Choking	Number per day	up to 1 month
Secondary	Infections	Fever or other acute illness episode	up to 1 month