Oral Feeding Ability of Preterm Infants With Breastfeeding Support System

NCT05675891 | Unknown DMC

• 1 other identifier: HRU-BOZDAG-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This research 34.-36. is carried out as a randomized controlled experimental design in order to evaluate the effectiveness of the supplemental feeding system to improve the early feeding skills of preterm infants receiving care in the neonatal intensive care unit at the gestational week.The universe of this research will consist of preterm infants hospitalized in the neonatal intensive care of Sanlıurfa Training and Research Hospital between July 2022 and April 2023. The sample size in the study was "H00: There is no difference between preterm infants with supplemental feeding system and preterm infants fed with bottle in terms of early feeding skills." According to the hypothesis G\*Power Version 3.1.9.2 (Franz Foul, Universitat Kiel, Germany) was calculated in the program. In order to determine the difference between the groups, the number of groups is 2; number of repeated measurements 3; correlation between repeated measurements 0.5; Cohen\* effect size 0.25; The statistical power was determined as a sample size of 44 preterm infants, 22 of whom were fed with supplemental feeding system and 22 of whom were fed with bottle, with 95% and type 1 error of 5%. and infants assigned to groups by randomization method. Randomization in the study determined by entering the total number of cases through the program http://www.randomizer.org. Through this program, the infants forming the sample group randomly distributed to two groups and randomization made.

Conditions

Nutrition Disorder, Infant; Nutrition

Keywords

Preterm infants; Early feeding skills; Supplemental feeding system

Outcome Measures

Primary Outcomes (1)

• Early Feeding Skills

  Before, during and after three feedings between 08:00 and 16:00

  through study completion, an average of 10 days

Secondary Outcomes (3)

• Physiological parameters 1 (peak heart rate/minute)

  through study completion, an average of 10 days

• Physiological parameters 2 (oxygen saturation/ %)

  through study completion, an average of 10 days

• Physiological parameters 3 (respiratory rate/minute)

  through study completion, an average of 10 days

Study Arms (2)

Supplemental Feeding System Group

EXPERIMENTAL

3 feeding between 08-16:00 are carried out with the supplemental feeding system. The remaining 5 feedings continue with the bottle.

Other: Supplemental Feeding System Group

Bottle Feeding Group (Control)

NO INTERVENTION

All feedings are made from a bottle.

Interventions

Supplemental Feeding System Group OTHER

The body weight is measured in the morning fasting on the day when oral feeding is decided, 3 feeding between 08-16:00 are carried out with the supplemental feeding system, The amount of food prepared is recorded, Heart rate, oxygen saturation, respiratory rate and early feeding skill score are recorded before, during and after feeding, When the feeding is finished, the total amount of food taken by the baby and the feeding time are recorded, The rate of food intake (%) and the amount of food received per minute are calculated and recorded, Infants who can take 80% of the amount of food given at each meal by being fed orally for 8 meals two days in a row are considered to have switched to full oral feeding.

Supplemental Feeding System Group

Eligibility Criteria

• Age: 34 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Postmenstrual age between 34-36 weeks (preterm babies at 34 and 36 weeks of gestation will be included),
• Over 1500 g,
• Switching to oral feeding after feeding with orogastric tube,
• Breastfed during gavage feeding,
• Those who have not completed the first 24 hours in the transition from orgastric tube feeding to the oral feeding process,
• Having cues of readiness for feeding (tolerating enteral nutrition, having a stable oxygen saturation and respiration during feeding, having the ability to lick, swallow and suck, react when mouth and lip are given stimuli),
• The mother's willingness to breastfeed her baby,
• Preterm infants of parents who volunteered to participate in the study will be included.

You may not qualify if:

• Having diseases other than being preterm,
• Capable of successfully taking the breast at the first attempt (Early Feeding Skill/EFS: 57),
• With congenital anomaly,
• With chromosomal disorders,
• With sepsis,
• With intracranial bleeding,
• Those with a very low birth weight below 1500 g and
• Preterm babies younger than 34 weeks of gestation will be excluded.

Sponsors & Collaborators

• Harran University: lead

Study Sites (1)

Harran University

Sanliurfa, 63050, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Infant Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Fatma BOZDAĞ, Lecturer

  Harran University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatma BOZDAĞ, Lecturer

CONTACT

+90 541 775 27 08; fatmabozdag@harran.edu.tr

Duygu GÖZEN, Professor

CONTACT

+90 532 706 50 65; duygu.gozen@iuc.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer Doctor

Study Record Dates

• First Submitted: December 10, 2022
• First Posted: January 9, 2023
• Study Start: July 20, 2022
• Primary Completion: August 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 12, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)