- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06204263
The Effect of the Finger Feeding Method Premature Babies
January 11, 2024 updated by: Zülbiye demir barbak, Ataturk University
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.
Study Overview
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 Type
Interventional
Enrollment (Estimated)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zülbiye DEMİR BARBAK
- Phone Number: +904422314066
- Email: zulbiye.demir@atauni.edu.tr
Study Contact Backup
- Name: FATMA KURUDİREK
- Phone Number: +905435164229
- Email: fatmasaban25@hotmail.com
Study Locations
-
-
Center
-
Erzurum, Center, Turkey, 25240
- Zülbiye DEMİR BARBAK
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
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: Experimental Group
The baby will be allowed to suck his father's finger for five minutes three times a day before nasogastric feeding.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preterm Baby Monitoring Form
Time Frame: Baseline
|
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.
|
Baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
LATCH Breastfeeding Diagnostic Measurement Tool
Time Frame: Baseline
|
It was developed in Oregon by Jensen and Wallace in 1993.
LATCH Breastfeeding Diagnosis Form consists of five evaluation criteria: L(Latch on breast), A(Audible swallowing), T(Type of nipple), C(Comfort breast /nipple) and H(Hold / Help) Each item is evaluated between 0-2 points.
The lowest score from the scale is 0 and the highest score is 10.
High scores indicate the baby's sucking success.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: HASAN KAHVECİ, zulbiye.demir@atauni.edu.tr
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
February 15, 2024
Primary Completion (Estimated)
February 20, 2024
Study Completion (Estimated)
August 20, 2024
Study Registration Dates
First Submitted
January 3, 2024
First Submitted That Met QC Criteria
January 11, 2024
First Posted (Actual)
January 12, 2024
Study Record Updates
Last Update Posted (Actual)
January 12, 2024
Last Update Submitted That Met QC Criteria
January 11, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AtaU-HEM-ZDB-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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