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CompletedNCT06737796Updated Dec 17, 2024

The Effect of Different Feeding Methods on Infants

An interventional study of Finger Feeding and syringe feeding in Preterm Infants, Injector and Finger, sponsored by Aydin Adnan Menderes University. Completed at 1 site in Turkey. Open to participants aged 32 Weeks to 37 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-17.

Sponsored by Aydin Adnan Menderes University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Dec 2021, registered Jan 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
32 Weeks to 37 Weeks
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Preterm Infants
  • Injector
  • Finger
  • Sucking Success
  • Nursing Caries

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03

In context

Premature Birth

2,557 studies on the registry are indexed under Premature Birth; 500 are open to participants now.

This study's enrollment of 74 is below the median of 84 across 1,691 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Aydin Adnan Menderes University is the lead sponsor of 236 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
32 Weeks to 37 Weeks
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
74 participants (actual)

Study arms

  • 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.

    Behavioral: Finger Feeding

  • 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.

    Behavioral: syringe feeding

Interventions

  • BehavioralFinger Feeding

    feeding method

  • Behavioralsyringe feeding

    feeding method

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: avarege four days

  2. 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.

    Time frame: avarege four days

  3. 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.

    Time frame: avarege four days

07

Study locations

1 site
  • Aydın Adnan Menderes Univercity
    Aydın, Efeler 0900, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06737796
Lead sponsor
Aydin Adnan Menderes University
Responsible party
Tugba Yapar (Principal investigator, Aydin Adnan Menderes University) — Principal investigator
First posted
Dec 17, 2024
Start date
Dec 1, 2021
Primary completion
Jun 1, 2023
Completion
Jan 1, 2024
Last update
Dec 17, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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