Low-Birth-Weight InfantNCT04036240
Finger Feeding as a Method of HMF Supplementation After Discharge
A study testing Finger feeding in people with Low-Birth-Weight Infant and Breast Feeding, run by Fakultas Kedokteran Universitas Indonesia at 4 sites in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 3 days and older
- Conditions the study is for
- Low-Birth-Weight Infant, Breast Feeding
- What is being tested?
- Finger feeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 4 sitesIndonesia
- Study dates
- 22 Jul 2019to 31 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- major congenital anomaly or other conditions interfere with normal growth and oral feeding
Trial locations and contacts
4 sites in 1 country.
Aryono Hendarto, PhD contact
Indonesia4 sites, 4 recruiting
- Recruiting
RS Hermina Bekasi
Bekasi, West Java, 17141
Elsa
- Recruiting
RS Hermina Jatinegara
Jakarta, 13320
Angeline Adrianne, MD, +6282177777611, angeline.adrianne@icloud.com
Angeline Adrianne, MD
- Recruiting
Koja District Hospital
Jakarta, 14230
Afaf Susilawati, MD, susilawatiafaf@gmail.com
Afaf Susilawati, MD
- Recruiting
Budi Kemuliaan Hospital
Jakarta Pusat, Jakarta Special Capital Region, 10110
Irma Sapriani, MD
Yoga Devaera, MD
About this study
Official title: Finger Feeding as a Method of Human Milk Supplementation in Low Birth Weight Infants After Discharge: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Low-Birth-Weight Infant, Breast Feeding
- Being tested
- Finger feeding
- Keywords
- low birth weight infant, breast milk supplementation, finger feeding
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finger feedingOther
After discharge, subjects will be given HMF supplementation by finger feeding method using finger feeder
| Study group | Role | What they receive |
|---|---|---|
| Finger feeder | Experimental | HMF supplementation will be given by finger feeder Receives: Other: Finger feeding |
| Control | No intervention | HMF supplementation will be given by mother preference such as cup, bottle. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding rate
Formula used (ml/kg/day)
Measured: 28 days
Secondary outcomes (7)
Growth
mean difference in weight, length, head circumference; skin fol thickness (mm)
Measured: 28 days
Compliance
Number of supplementation per day
Measured: 28 days
Stool consistency
Diapered infant stool scale (1-5B)
Measured: up to 1 month
Stool frequency
Number of stool per day
Measured: up to 1 month
Vomiting
number per day
Measured: 4 weeks
Choking
Number per day
Measured: up to 1 month
Infections
Fever or other acute illness episode
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start22 Jul 2019
- Primary completion30 Dec 2019 (estimated)
- Study completion31 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low-Birth-Weight InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fakultas Kedokteran Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich
- Responsible party
- Principal investigator, YogaD, Fakultas Kedokteran Universitas Indonesia
- Investigators
- Yoga Devaera, MD, Principal investigator, Fakultas Kedokteran Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036240
- Sponsor's protocol ID
- 2019-05-0711
- Status last verified
- Dec 2019
- First submitted
- 22 Jul 2019
- Last updated
- 27 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD in results after publication
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finger Feeding as a Method of Human Milk Supplementation in Low Birth Weight Infants After Discharge: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04036240
- Acronym / sponsor ID
- 2019-05-0711
- Conditions
- Low-Birth-Weight Infant, Breast Feeding
- Keywords
- low birth weight infant, breast milk supplementation, finger feeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Fakultas Kedokteran Universitas IndonesiaUniversity, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 31 Jan 2020 (estimated)
- First posted
- 29 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Finger feeder | Experimental | Other: Finger feedingHMF supplementation will be given by finger feeder |
| Control | No intervention | –HMF supplementation will be given by mother preference such as cup, bottle. |
Who may qualify
- Ages
- 3 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- major congenital anomaly or other conditions interfere with normal growth and oral feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Finger feedingAfter discharge, subjects will be given HMF supplementation by finger feeding method using finger feeder | Other | Finger feeder |
Primary outcome
Breastfeeding rate
Time frame: 28 days
Formula used (ml/kg/day)
7 secondary outcomes
Growth
Time frame: 28 days
Compliance
Time frame: 28 days
Stool consistency
Time frame: up to 1 month
Stool frequency
Time frame: up to 1 month
Vomiting
Time frame: 4 weeks
Choking
Time frame: up to 1 month
Infections
Time frame: up to 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2019.
- Individual participant dataSharing planned: Yes. All IPD in results after publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aryono Hendarto, PhD contact
Yoga Devaera, MD principal investigator
Fakultas Kedokteran Universitas Indonesia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Finger feeding in people with Low-Birth-Weight Infant and Breast Feeding, run by Fakultas Kedokteran Universitas Indonesia at 4 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yoga Devaera, MD (+628129431861, yoga.devaera@ui.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breastfeeding rate (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2019; AzTrials last refreshed its copy on 7 Nov 2026.