Oral Feeding Ability of Preterm Infants With Breastfeeding Support System

October 11, 2023 updated by: Fatma BOZDAG, Harran University

The Effect of Supplemental Feeding System on Preterm Infants' Oral Feeding Skils: Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
      • Sanlıurfa, Turkey, 63050
        • Recruiting
        • Harran University
        • Contact:
        • Sub-Investigator:
          • Hilal BERBER ÇİFTCİ, Lecturer
        • Sub-Investigator:
          • Duygu GÖZEN, Professor
        • Sub-Investigator:
          • Mehmet Emin AVLANMIŞ, Pediatrician
        • Sub-Investigator:
          • Neslihan ATLI, Midwife

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 months to 8 months (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Supplemental Feeding System Group
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
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.
No Intervention: Bottle Feeding Group (Control)
All feedings are made from a bottle.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Early Feeding Skills
Time Frame: through study completion, an average of 10 days
Before, during and after three feedings between 08:00 and 16:00
through study completion, an average of 10 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Physiological parameters 1 (peak heart rate/minute)
Time Frame: through study completion, an average of 10 days
Before, during and after three feedings between 08:00 and 16:00
through study completion, an average of 10 days
Physiological parameters 2 (oxygen saturation/ %)
Time Frame: through study completion, an average of 10 days
Before, during and after three feedings between 08:00 and 16:00
through study completion, an average of 10 days
Physiological parameters 3 (respiratory rate/minute)
Time Frame: through study completion, an average of 10 days
Before, during and after three feedings between 08:00 and 16:00
through study completion, an average of 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Harran University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fatma BOZDAĞ, Lecturer, Harran University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 20, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HRU-BOZDAG-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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