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Finger Feeding as a Method of HMF Supplementation After Discharge

Primary Purpose

Low-Birth-Weight Infant, Breast Feeding

Status
Unknown status
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Finger feeding
Sponsored by
Fakultas Kedokteran Universitas Indonesia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low-Birth-Weight Infant focused on measuring low birth weight infant, breast milk supplementation, finger feeding

Eligibility Criteria

3 Days - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Budi Kemuliaan HospitalRecruiting
  • RS Hermina BekasiRecruiting
  • RS Hermina JatinegaraRecruiting
  • Koja District HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Finger feeder

Control

Arm Description

HMF supplementation will be given by finger feeder

HMF supplementation will be given by mother preference such as cup, bottle.

Outcomes

Primary Outcome Measures

Breastfeeding rate
Formula used (ml/kg/day)

Secondary Outcome Measures

Growth
mean difference in weight, length, head circumference; skin fol thickness (mm)
Compliance
Number of supplementation per day
Stool consistency
Diapered infant stool scale (1-5B)
Stool frequency
Number of stool per day
Vomiting
number per day
Choking
Number per day
Infections
Fever or other acute illness episode

Full Information

First Posted
July 22, 2019
Last Updated
December 24, 2019
Sponsor
Fakultas Kedokteran Universitas Indonesia
Collaborators
Ludwig-Maximilians - University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT04036240
Brief Title
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

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 22, 2019 (Actual)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
January 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fakultas Kedokteran Universitas Indonesia
Collaborators
Ludwig-Maximilians - University of Munich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low-Birth-Weight Infant, Breast Feeding
Keywords
low birth weight infant, breast milk supplementation, finger feeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Finger feeder
Arm Type
Experimental
Arm Description
HMF supplementation will be given by finger feeder
Arm Title
Control
Arm Type
No Intervention
Arm Description
HMF supplementation will be given by mother preference such as cup, bottle.
Intervention Type
Other
Intervention Name(s)
Finger feeding
Intervention Description
After discharge, subjects will be given HMF supplementation by finger feeding method using finger feeder
Primary Outcome Measure Information:
Title
Breastfeeding rate
Description
Formula used (ml/kg/day)
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Growth
Description
mean difference in weight, length, head circumference; skin fol thickness (mm)
Time Frame
28 days
Title
Compliance
Description
Number of supplementation per day
Time Frame
28 days
Title
Stool consistency
Description
Diapered infant stool scale (1-5B)
Time Frame
up to 1 month
Title
Stool frequency
Description
Number of stool per day
Time Frame
up to 1 month
Title
Vomiting
Description
number per day
Time Frame
4 weeks
Title
Choking
Description
Number per day
Time Frame
up to 1 month
Title
Infections
Description
Fever or other acute illness episode
Time Frame
up to 1 month
Other Pre-specified Outcome Measures:
Title
Mothers's opinion about finger feeder supplementation
Description
In depth interview with guided questionnaire about using finger feeder at home (qualitative data)
Time Frame
up to 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yoga Devaera, MD
Phone
+628129431861
Email
yoga.devaera@ui.ac.id
First Name & Middle Initial & Last Name or Official Title & Degree
Aryono Hendarto, PhD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoga Devaera, MD
Organizational Affiliation
Fakultas Kedokteran Universitas Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Budi Kemuliaan Hospital
City
Jakarta Pusat
State/Province
Jakarta
ZIP/Postal Code
10110
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irma Sapriani, MD
First Name & Middle Initial & Last Name & Degree
Yoga Devaera, MD
First Name & Middle Initial & Last Name & Degree
Irma Sapriani, MD
Facility Name
RS Hermina Bekasi
City
Bekasi
State/Province
Jawa Barat
ZIP/Postal Code
17141
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elsa
Facility Name
RS Hermina Jatinegara
City
Jakarta
ZIP/Postal Code
13320
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angeline Adrianne, MD
Phone
+6282177777611
Email
angeline.adrianne@icloud.com
First Name & Middle Initial & Last Name & Degree
Angeline Adrianne, MD
Facility Name
Koja District Hospital
City
Jakarta
ZIP/Postal Code
14230
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Afaf Susilawati, MD
Email
susilawatiafaf@gmail.com
First Name & Middle Initial & Last Name & Degree
Afaf Susilawati, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD in results after publication
IPD Sharing Time Frame
After publication
IPD Sharing Access Criteria
systematic review proposal

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Finger Feeding as a Method of HMF Supplementation After Discharge

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