- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06737796
The Effect of Different Feeding Methods on Infants
The Effect of Different Feeding Methods on Infant's Weight, Full Oral Feeding Transition Time and Success of Breastfeeding in Preterm Infants
Objective: The aim of this study was to investigate the effect of finger feeding and syringe feeding methods on infant weight, time to full oral feeding and breastfeeding success in preterm infants.
H01: There is no difference between the weights of preterm babies fed by finger and by syringe.
H02: There is no difference in the transition time between finger-fed and syringe-fed preterm babies to full oral feeding.
H03: There is no difference between breastfeeding success between finger and syringe feeding methods.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Efeler
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Aydın, Efeler, Turkey, 0900
- Aydın Adnan Menderes Univercity
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Having a gestational age between 32 weeks and 36+6 weeks,
- Weighing 1500 g or more,
- Having spontaneous breathing (can receive free oxygen, incubator oxygen),
- Those who have been fed only by gavage or parenterally and are ready to switch to oral feeding,
- Preterm babies whose parents were literate in Turkish and gave consent were included in the study.
Exclusion Criteria:
- Those who were fed orally before the research,
- Those who need noninvasive mechanical ventilation such as CPAP,
- Babies with metabolic diseases were excluded from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: experimental 1
Preterm babies in the finger feeding group, which constituted the study group, were finger fed by the neonatal intensive care nurse responsible for the baby's care, three times a day for no more than 20 minutes.
If babies had breast milk during feedings, breast milk was given first.
Formula milk was used when breast milk was not available.
The amount of milk that the preterm baby should receive, determined by the neonatal specialist physician, was completed after the planned 20 minutes of feeding time and at other feeding meals during the day, according to the clinic's feeding protocol.
In addition, preterm babies have three meals a day; Heart rate, respiration and saturation before and after feeding, and evaluation of feeding duration, amount of feeding and vomiting at the end of feeding were recorded in PBIF.
The Preterm Baby Monitoring Form, which was planned to be used at this stage, was filled out by the neonatal intensive care nurse or the researcher.
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feeding method
|
|
Experimental: experimental 2
Preterm babies in the syringe feeding group, which constituted the other study group, were fed with a syringe three times a day for no more than 20 minutes by the neonatal intensive care nurse responsible for the baby's care.
If babies had breast milk during feedings, breast milk was given first.
Formula milk was used when breast milk was not available.
The amount of milk that the preterm baby should receive, determined by the neonatal specialist physician, was completed after the planned 20 minutes of feeding time and at other feeding meals during the day, according to the clinic's feeding protocol.
In addition, preterm babies have three meals a day; Heart rate, respiration and saturation before and after feeding, and evaluation of feeding duration, amount of feeding and vomiting at the end of feeding were recorded in PBIF.
The Preterm Baby Monitoring Form, which was planned to be used at this stage, was filled out by the neonatal intensive care nurse or the researcher.
|
feeding method
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mother and Preterm Baby Introductory Information Form (APBTBF):
Time Frame: avarege four days
|
Mother and Preterm Baby Introductory Information Form (APBTBF): The questionnaire prepared by the researcher in line with the literature includes introductory information about the preterm baby (delivery type, baby's birth date and time, hospitalization date and time, hospitalization diagnosis, gestational age, corrected gestational age, gender).
, birth weight, birth length, birth head circumference, weight at the start of the study, birth order, whether the mother was breastfed or not, whether the mother was educated about expressing her milk, discharge weight, date and time of the baby's discharge from the hospital) and descriptive information about the mother (age, education).
It consists of 22 questions asking about breastfeeding level, previous breastfeeding experience, breastfeeding duration if breastfeeding, and previous birth to a preterm baby).
|
avarege four days
|
|
Preterm Baby Follow-up Form (PBIF):
Time Frame: avarege four days
|
Preterm Baby Follow-up Form (PBIF): It is a follow-up form developed by the researcher in line with the literature in order to follow the preterm baby from the moment he starts feeding with an alternative feeding method.
In this form, the preterm baby's birth, transition to oral feeding, transition to breastfeeding and discharge dates, as well as information on body weight, head circumference and height at these stages; Information on heart rate (HR), respiratory rate and oxygen saturation (SpO2) values before and after feeding, presence of vomiting after feeding, full oral feeding amounts and feeding durations are included.
|
avarege four days
|
|
Breastfeeding Diagnostic Measurement Tool (LATCH):
Time Frame: avarege four days
|
Breastfeeding Diagnostic Measurement Tool (LATCH): LATCH was developed by Deborah Jensen and Sheilla Wallace in 1993.
The adaptation of the scale into Turkish and its validity and reliability studies were first carried out in a Master's Thesis study by Demirhan and Pek in 1997, but this study was not published.
The second validity and reliability study was conducted by Yenal and Okumuş in 2003.
In the application of the scale, the mother is observed by a midwife/nurse while breastfeeding, and the form is filled out by evaluating the mother and the baby in line with the criteria.
The application time of the scale is 5-10 minutes.
While the Cronbah alpha value of the original version of the vehicle was found to be 0.93, it was found to be 0.95 in the Turkish adaptation study.
The measurement tool consists of five evaluation items/criteria.
|
avarege four days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Adnan Menderes Univercity
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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