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Oral Feeding Ability of Preterm Infants With Breastfeeding Support System

Primary Purpose

Nutrition Disorder, Infant, Nutrition

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Supplemental Feeding System Group
Sponsored by
Harran University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nutrition Disorder, Infant focused on measuring Preterm infants, Early feeding skills, Supplemental feeding system

Eligibility Criteria

34 Weeks - 36 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Harran UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Supplemental Feeding System Group

Bottle Feeding Group (Control)

Arm Description

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

All feedings are made from a bottle.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Physiological parameters 1 (peak heart rate/minute)
Before, during and after three feedings between 08:00 and 16:00
Physiological parameters 2 (oxygen saturation/ %)
Before, during and after three feedings between 08:00 and 16:00
Physiological parameters 3 (respiratory rate/minute)
Before, during and after three feedings between 08:00 and 16:00

Full Information

First Posted
December 10, 2022
Last Updated
October 11, 2023
Sponsor
Harran University
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1. Study Identification

Unique Protocol Identification Number
NCT05675891
Brief Title
Oral Feeding Ability of Preterm Infants With Breastfeeding Support System
Official Title
The Effect of Supplemental Feeding System on Preterm Infants' Oral Feeding Skils: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2022 (Actual)
Primary Completion Date
August 1, 2023 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harran University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Written and verbal consents are obtained by informing the mothers about the study, and the information about the preterm infants and their mothers is recorded. Preterm infants, whose transition to oral feeding was decided by the physician and nurse and whose families gave consent to participate in the study, were randomly assigned to 2 groups as experimental (supplemental feeding system; SFS) and control (bottle feeding group; BFG). After oral feeding is decided, the first feeding of preterm infants in both groups is tried directly on the mother's breast and the early feeding skill score is 57, with heart rate (120-160/min), sPO2(>90) and respiratory rates (40-60/min) during the time they are at the mother's breast. min) are not included in the study, whose follow-ups are between normal values. The first feeding of the infants in both groups is carried out between 08:00 and 16:00 and the body weights of the infants are measured daily with the same scale before feeding.The amount in which the food (breast milk) is prepared to be given orally to the baby is recorded. The feeding time of all infants was limited to a maximum of 30 minutes. The feeding time of the infants are recorded in the feeding follow-up form. Before, during and after feeding, the heart rate, SPO2 and respiratory rates of the infants are recorded by pulse oximetry. During feeding, infants are evaluated with their early feeding skills by an observing nurse and their scores are recorded. Physiological parameters of infants are recorded before, during and after feeding is started, infants who are desaturated (SPO2 below 90%) during feeding are rested and feeding is continued after their saturation rises above 90% and these rest periods are also included in the feeding. After the decision to switch to oral feeding, the infants in the experimental group are fed 3 meals a day with the supplemental feeding system (daytime feedings), other meals are carried out with a bottle, and all the feedings of the infants in the control group are carried out with a bottle, which is the service routine. Infants' nutritional skills are evaluated at each meal, and their physiological measurements are recorded. After the evaluations of the infants who could not take the whole recommended amount of food in both groups (feeding time, recommended amount of food, amount of food the infant took, early feeding skill score and physiological parameters were recorded, the nurse completes the feeding of the infant with a bottle. The infants are followed up between 8-16 hours. The evaluations made at 3 meals are recorded. Infants who are fed orally for 8 meals a day for two consecutive days, and who can take 80% of the amount of food given at each meal, are considered to have switched to full oral feeding and the follow-up of the ınfants are stopped. The study followed the CONSORT guideline for reporting randomized controlled trials.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutrition Disorder, Infant, Nutrition
Keywords
Preterm infants, Early feeding skills, Supplemental feeding system

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Supplemental Feeding System Group
Arm Type
Experimental
Arm Description
3 feeding between 08-16:00 are carried out with the supplemental feeding system. The remaining 5 feedings continue with the bottle.
Arm Title
Bottle Feeding Group (Control)
Arm Type
No Intervention
Arm Description
All feedings are made from a bottle.
Intervention Type
Other
Intervention Name(s)
Supplemental Feeding System Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Early Feeding Skills
Description
Before, during and after three feedings between 08:00 and 16:00
Time Frame
through study completion, an average of 10 days
Secondary Outcome Measure Information:
Title
Physiological parameters 1 (peak heart rate/minute)
Description
Before, during and after three feedings between 08:00 and 16:00
Time Frame
through study completion, an average of 10 days
Title
Physiological parameters 2 (oxygen saturation/ %)
Description
Before, during and after three feedings between 08:00 and 16:00
Time Frame
through study completion, an average of 10 days
Title
Physiological parameters 3 (respiratory rate/minute)
Description
Before, during and after three feedings between 08:00 and 16:00
Time Frame
through study completion, an average of 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
34 Weeks
Maximum Age & Unit of Time
36 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fatma BOZDAĞ, Lecturer
Phone
+90 541 775 27 08
Email
fatmabozdag@harran.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Duygu GÖZEN, Professor
Phone
+90 532 706 50 65
Email
duygu.gozen@iuc.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatma BOZDAĞ, Lecturer
Organizational Affiliation
Harran University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harran University
City
Sanlıurfa
ZIP/Postal Code
63050
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatma BOZDAĞ, Lecturer
Phone
+90 541 775 27 08
Email
fatmabozdag@harran.edu.tr
First Name & Middle Initial & Last Name & Degree
Hilal BERBER ÇİFTCİ, Lecturer
First Name & Middle Initial & Last Name & Degree
Duygu GÖZEN, Professor
First Name & Middle Initial & Last Name & Degree
Mehmet Emin AVLANMIŞ, Pediatrician
First Name & Middle Initial & Last Name & Degree
Neslihan ATLI, Midwife

12. IPD Sharing Statement

Plan to Share IPD
No

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Oral Feeding Ability of Preterm Infants With Breastfeeding Support System

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