Finger Feeding as a Method of HMF Supplementation After D... | NCT04036240

Studies
Finger Feeding as a Method of HMF Supplementation After Discharge

NCT04036240

Sponsor

Fakultas Kedokteran Universitas Indonesia

Status

Unknown status

Last Update Posted

Dec 27, 2019Actual

Enrollment

78Estimated

Phase

Not Applicable

Conditions

Low-Birth-Weight Infant
Breast Feeding

Interventions

Finger feeding

Countries

Indonesia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 22, 2019Actual

Primary Completion Date

Dec 30, 2019Estimated

Completion Date

Jan 31, 2020Estimated

First Submitted Date

Jul 22, 2019

First Submission Date that Met QC Criteria

Jul 26, 2019

First Posted Date

Jul 29, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 24, 2019

Last Update Posted Date

Dec 27, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

YogaD, Head of Nutrition and Metabolic Diseases Division Dept of Child Health, Fakultas Kedokteran Universitas IndonesiaPrincipal Investigator

Lead Sponsor

Fakultas Kedokteran Universitas IndonesiaOTHER

Collaborators

Name	Class
Ludwig-Maximilians - University of Munich	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

78Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Finger feeder	Experimental	HMF supplementation will be given by finger feeder	Other: Finger feeding
Control	No Intervention	HMF supplementation will be given by mother preference such as cup, bottle.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Finger feeding	Other	After discharge, subjects will be given HMF supplementation by finger feeding method using finger feeder	Finger feeder

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Breastfeeding rate	Formula used (ml/kg/day)	28 days

Secondary Outcomes

Measure	Description	Time Frame
Growth	mean difference in weight, length, head circumference; skin fol thickness (mm)	28 days
Compliance	Number of supplementation per day

Other Outcomes

Measure	Description	Time Frame
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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Days

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yoga Devaera, MD	Contact	+628129431861		yoga.devaera@ui.ac.id
Aryono Hendarto, PhD	Contact

Overall Officials

Name	Affiliation	Role
Yoga Devaera, MD	Fakultas Kedokteran Universitas Indonesia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Budi Kemuliaan Hospital	Recruiting	Jakarta Pusat	Jakarta Special Capital Region	10110	Indonesia

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All IPD in results after publication

Types

Study Protocol

Time Frame

After publication

Access Criteria

systematic review proposal

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001942	Breast Feeding

Ancestor Terms

ID	Term
D005247	Feeding Behavior
D001519	Behavior

Browse Leaves

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Browse Branches

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