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The Effect of Different Feeding Methods on Infants

NCT ID: NCT06737796

Last Updated: 2024-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2024-01-01

Brief Summary

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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.

Detailed Description

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The study was conducted as a parallel groups randomized experimental study. The study was conducted between December 1, 2021 and June 1, 2023 in the Neonatal Intensive Care Unit of Aydın Obstetrics and Gynecology Hospital. The sample included preterm infants with 320/7-366/7 gestation weeks who were receiving care and treatment in the neonatal intensive care unit. In the sample, n=38 infants were randomly assigned to study group 1 and n=36 infants to study group 2 and the study was completed with n=74 infants. The data were collected using the Preterm Infant Information Form, Preterm Infant Follow-up Form and LATCH Breastfeeding Diagnostic Measurement Tool. The babies selected for the study group were fed with the method of whichever study group they were added to (finger or syringe feeding) at three feeding meals each day. After switching to full oral feeding, breastfeeding success was measured with the breastfeeding diagnostic measurement tool (LATCH), which was used when the infants first held the breast and the time of transition to full oral feeding. The difference between groups was analyzed using Mann Whitney U analysis for non-normally distributed data and the difference between groups for normally distributed data was analyzed using independent two sample t test. Homogeneity of variances was assessed by Levene's test. Since the standard error indicates the spread of the means of the samples selected from the same population and the standard deviation indicates the distance of each individual in the group from the mean, the standard error values were given together with the means in the analyses comparing the group means.

Conditions

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Preterm Infants Injector Finger Sucking Success Nursing Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Finger Feeding

Intervention Type BEHAVIORAL

feeding method

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.

Group Type EXPERIMENTAL

syringe feeding

Intervention Type BEHAVIORAL

feeding method

Interventions

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Finger Feeding

feeding method

Intervention Type BEHAVIORAL

syringe feeding

feeding method

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

32 Weeks

Maximum Eligible Age

37 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aydin Adnan Menderes University

OTHER

Sponsor Role lead

Responsible Party

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Tugba Yapar

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aydın Adnan Menderes Univercity

Aydin, efeler, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Adnan Menderes Univercity

Identifier Type: -

Identifier Source: org_study_id