The Effect of Different Feeding Methods on Infants
1 other identifier
interventional
74
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2024
CompletedFirst Submitted
Initial submission to the registry
January 17, 2024
CompletedFirst Posted
Study publicly available on registry
December 17, 2024
CompletedDecember 17, 2024
December 1, 2024
1.5 years
January 17, 2024
December 12, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Mother and Preterm Baby Introductory Information Form (APBTBF):
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):
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):
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
Study Arms (2)
experimental 1
EXPERIMENTALPreterm 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.
experimental 2
EXPERIMENTALPreterm 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aydın Adnan Menderes Univercity
Aydin, efeler, 0900, Turkey (Türkiye)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
January 17, 2024
First Posted
December 17, 2024
Study Start
December 1, 2021
Primary Completion
June 1, 2023
Study Completion
January 1, 2024
Last Updated
December 17, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share