NCT06737796

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2024

Completed
11 months until next milestone

First Posted

Study publicly available on registry

December 17, 2024

Completed
Last Updated

December 17, 2024

Status Verified

December 1, 2024

Enrollment Period

1.5 years

First QC Date

January 17, 2024

Last Update Submit

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

EXPERIMENTAL

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.

Behavioral: Finger Feeding

experimental 2

EXPERIMENTAL

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.

Behavioral: syringe feeding

Interventions

Finger FeedingBEHAVIORAL

feeding method

experimental 1
syringe feedingBEHAVIORAL

feeding method

experimental 2

Eligibility Criteria

Age32 Weeks - 37 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

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)

Location

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

Locations