PrematureNCT06204263
The Effect of the Finger Feeding Method Premature Babies
A study testing finger feeding in people with Premature, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to determine the effect of the finger feeding method applied by fathers on the transition time to oral feeding and sucking success in premature babies. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Premature
- What is being tested?
- finger feeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2024to 20 Aug 2024
- 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Premature babies at 29-31 weeks
- Birth weight of 1300 g or more
- Those whose 1st and 5th minute Apgar scores are over 6
- Those whose vital signs and health status are stable
- In babies who have received mechanical ventilation and continuous positive air pressure support, those who have passed 48 hours after stability has been achieved
- No facial or oral anomalies
Show all 10Show fewer
- Premature babies without swallowing difficulties
- Those fed via nasogastric tube
- Fathers who can read, write and speak Turkish
- Fathers of preterm babies who agreed to participate in the research.
Who cannot join
- Those whose vital and health conditions are unstable
- Those whose father has a skin condition or those who developed it later
- Any upper respiratory tract infection in the father
- Premature babies without swallowing difficulties
- Fathers who cannot read, write or speak Turkish
- Fathers with preterm babies who do not consent to this study will not be included in the scope of the research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Finger Feeding Method Applied by Fathers on the Transition Time to Oral Feeding and Sucking Success in Premature Babies
This study aimed to determine the effect of the finger feeding method applied by fathers on the transition time to oral feeding and sucking success in premature babies.
Read the detailed description
Premature babies followed in the Neonatal Intensive Care Unit will be randomly divided into two groups: control group and finger-feeding group. Babies in the experimental group will be breastfed by their father three times a day. Before nasogastric feeding, the baby will be allowed to suck his finger by putting his finger in his mouth for five minutes three times a day. This procedure will be applied three times a day (morning, noon and evening) for a full 7 days. Babies in the control group will be given only routine ward care (breast milk or formula via tube without stimulation of the pacifier or mother's finger). Preterm Baby Monitoring Form and LATCH Breastfeeding Diagnostic Measurement Tool will be used to determine the transition time to oral feeding and breastfeeding success.
- Conditions
- Premature
- Being tested
- finger feeding
- Keywords
- Premature, Finger, Father, Feeding
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
finger feedingOther
The fathers of premature babies in intensive care will be interviewed and an educational booklet will be prepared about finger feeding, cleaning, hygiene, hand washing, the importance of sucking, and the rules to be followed to prevent infection in the newborn, and how to apply it will be explained by the researcher. Babies will be breastfed three times a day for seven days.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Babies in the control group will be given only routine ward care (breast milk or formula via tube without stimulation of the pacifier or mother's finger). |
| Experimental Group | Experimental | The baby will be allowed to suck his father's finger for five minutes three times a day before nasogastric feeding. Receives: Other: finger feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Identification Form
This form contains information such as the age of the mother and father, the baby's weight, time to independent oral feeding, discharge weight, length of hospital stay, fetal age at birth, Apgar score, gender of the baby, etc.
Measured: Baseline
Secondary outcomes (1)
Preterm Baby Monitoring Form
During the study process, it will be used to record the preterm baby's "first finger feeding, transition to oral feeding, first latch on the mother's breast, transition to full mother's breast, discharge dates and body weight at these stages, as well as the finger feeding chart" information.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start15 Feb 2024 (estimated)
- Primary completion20 Feb 2024 (estimated)
- Study completion20 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PrematureStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zülbiye demir barbak, Ataturk University
- Investigators
- HASAN KAHVECİ, Study chair, zulbiye.demir@atauni.edu.tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204263
- Sponsor's protocol ID
- AtaU-HEM-ZDB-01
- Status last verified
- Jan 2024
- First submitted
- 3 Jan 2024
- Last updated
- 12 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Buldur E, Yalcin Baltaci N, Terek D, Yalaz M, Altun Koroglu O, Akisu M, Kultursay N. Comparison of the Finger Feeding Method Versus Syringe Feeding Method in Supporting Sucking Skills of Preterm Babies. Breastfeed Med. 2020 Nov;15(11):703-708. doi: 10.1089/bfm.2020.0043. Epub 2020 Sep 11.
PubMed 32915053
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Finger Feeding Method Applied by Fathers on the Transition Time to Oral Feeding and Sucking Success in Premature Babies
- ClinicalTrials.gov ID
- NCT06204263
- Acronym / sponsor ID
- AtaU-HEM-ZDB-01
- Conditions
- Premature
- Keywords
- Premature, Finger, Father, Feeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 15 Feb 2024 (estimated)
- Primary completion
- 20 Feb 2024 (estimated)
- Study completion
- 20 Aug 2024 (estimated)
- First posted
- 12 Jan 2024 (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.
This study aimed to determine the effect of the finger feeding method applied by fathers on the transition time to oral feeding and sucking success in premature babies.
Detailed description
Premature babies followed in the Neonatal Intensive Care Unit will be randomly divided into two groups: control group and finger-feeding group. Babies in the experimental group will be breastfed by their father three times a day. Before nasogastric feeding, the baby will be allowed to suck his finger by putting his finger in his mouth for five minutes three times a day. This procedure will be applied three times a day (morning, noon and evening) for a full 7 days. Babies in the control group will be given only routine ward care (breast milk or formula via tube without stimulation of the pacifier or mother's finger). Preterm Baby Monitoring Form and LATCH Breastfeeding Diagnostic Measurement Tool will be used to determine the transition time to oral feeding and breastfeeding success.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Babies in the control group will be given only routine ward care (breast milk or formula via tube without stimulation of the pacifier or mother's finger). |
| Experimental Group | Experimental | Other: finger feedingThe baby will be allowed to suck his father's finger for five minutes three times a day before nasogastric feeding. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Premature babies at 29-31 weeks
- Birth weight of 1300 g or more
- Those whose 1st and 5th minute Apgar scores are over 6
- Those whose vital signs and health status are stable
- In babies who have received mechanical ventilation and continuous positive air pressure support, those who have passed 48 hours after stability has been achieved
Key exclusion criteria (6 listed)
- Those whose vital and health conditions are unstable
- Those whose father has a skin condition or those who developed it later
- Any upper respiratory tract infection in the father
- Premature babies without swallowing difficulties
- Fathers who cannot read, write or speak Turkish
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 feedingThe fathers of premature babies in intensive care will be interviewed and an educational booklet will be prepared about finger feeding, cleaning, hygiene, hand washing, the importance of sucking, and the rules to be followed to prevent infection in the newborn, and how to apply it will be explained by the researcher. Babies will be breastfed three times a day for seven days. | Other | Experimental Group |
Primary outcome
Patient Identification Form
Time frame: Baseline
This form contains information such as the age of the mother and father, the baby's weight, time to independent oral feeding, discharge weight, length of hospital stay, fetal age at birth, Apgar score, gender of the baby, etc.
1 secondary outcome
Preterm Baby Monitoring Form
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Results publication: PubMed 32915053Buldur E, Yalcin Baltaci N, Terek D, Yalaz M, Altun Koroglu O, Akisu M, Kultursay N. Comparison of the Finger Feeding Method Versus Syringe Feeding Method in Supporting Sucking Skills of Preterm Babies. Breastfeed Med. 2020 Nov;15(11):703-708. doi: 10.1089/bfm.2020.0043. Epub 2020 Sep 11.
- Randomized controlled studyLink provided by the sponsor.
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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.
HASAN KAHVECİ study chair
zulbiye.demir@atauni.edu.tr
1 site 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 Premature, run by Ataturk University at 1 site in Turkey (Türkiye).
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 10 inclusion and 6 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 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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 Zülbiye DEMİR BARBAK (+904422314066, zulbiye.demir@atauni.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Identification Form (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06204263, which also lists 1 linked publication.
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 12 Jan 2024.