Breastfeeding and Bottle Feeding: Impact on Preterm Infants' Physiology and Feeding Performance

April 5, 2025 updated by: Nagihan Sabaz, Istanbul University - Cerrahpasa

Effects of Breastfeeding and Bottle Feeding as the Initial Oral Feeding on Physiological Parameters and Feeding Performance in Preterm Infants: A Randomized Controlled Study

The goal of this clinical trial is to evaluate the effect of breastfeeding on the infant's test weight and physiological characteristics (oxygen saturation and heart rate) in preterm infants in the Neonatal Intensive Care Unit during the transition to oral feeding.

The main question it aims to answer are:

• Is there a difference in test weight and physiological parameters between the infants in whom the first oral feeding was performed by the mother and the infants in whom the first oral feeding was performed by the intensive care unit nurse with a bottle? Researchers will compare the breastfed group with the bottle-fed group to see if there are differences in test weight and physiological parameters.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In the pre-feeding stage of the research, the parents of the preterms included in the sample will be met and informed about the research. Written and verbal consent will be obtained from parents who agreed to participate in the study. "Preterm Infants Information Form" will be filled by the researcher before feeding and "Feeding Monitoring Form" will be filled during feeding. By randomization, it will be determined which of the experimental and control groups the preterm infant will be assigned to. It will be ensured that the interventions that will affect the vital signs of the preterms in both groups before feeding are not applied. Oxygen saturation and heart rate will be monitored for 30 minutes before, during and after feeding for all groups. Preterms in both groups will be dressed in clean and dry diapers by cleaning their bottoms before feeding, and will be weighed naked with a digital baby scale by removing their clothes. Weighing the preterms with an electronic precision balance before and after feeding - the test weighing - will be used to measure the amount of milk the preterm is expressing from the breast or bottle. The preterm will then be fed loosely wrapped in a cotton blanket. If the oxygen saturation level of all preterm infants falls below 90% during feeding, it will be considered desaturated and the feeding will be stopped. The preterm infants will continue to be fed when the oxygen saturation is ≥ 90% and the heart rate is 120-160/min. Feeding will be limited to a total of 30 minutes for infants in both groups, including rest intervals, and will not take longer. When the feeding is complete, preterms in both groups will be weighed naked without changing the diaper under the feeding process. It will be ensured that interventions that may affect the vital signs of all preterms included in the study are not applied when feeding is completed. The oxygen saturation and heart rate of the preterms in both groups will be monitored for 30 minutes after the feeding is completed. When feeding is complete, preterms in both groups will be placed on the same mother's breast in the right lateral position to facilitate gastric emptying.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • 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 Locations

  • Turkey
    • Istanbul
      • Avcılar, Istanbul, Turkey, 34320
        • IstanbulUC

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

Ages Eligible for Study

2 years to 2 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Gestation week at birth determined according to the mother's last menstrual date is 26-31+6 weeks,
  • Postmenstrual week at the time of the study was 32-36+6 weeks,
  • Having a body weight of 1500 grams or more at the time of inclusion in the study,
  • Suggested by the physician to switch to oral nutrition and switched from enteral nutrition to oral nutrition for the first time,
  • Breastfed,
  • Preterm infants whose parents' consent was obtained for inclusion in the study and whose parents signed the informed consent form

Exclusion Criteria:

  • Receiving oxygen,
  • Craniofacial anomalies such as cleft palate, cleft lip, facial muscle paralysis,
  • Preterm infants with any gastrointestinal, neurological and genetic disease (necrotizing enterocolitis, third and fourth level intracranial hemorrhage, periventricular leukomalacia, hydrocephalus, down syndrome, omphalocele, non-gastrodeia, short bowel syndrome and other diseases)

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Breastfeeding group
Preterm infants in this group are breastfed by their mothers during their first oral feeding. Before, during and after feeding, the preterm infant's oxygen saturation level and peak heart rate are measured for 30 minutes. In addition, the test test weighing is determined by weighing the baby before and after feeding.
Other: oral feeding

In experimental group infants: Preterms in this group will be breastfed by their own mother.

In control group infants: Preterms in this group will be fed by the researcher by putting the baby's own mother's milk in the bottle. During feeding, the preterm will be placed on the lap by the researcher in a standing position on the same mother's breast, and will be given a raised side-lying position. In this position, the preterm's head and body will be elevated 45-60 degrees with the help of a small pillow. While the researcher will support the preterm's head, neck and shoulder with one hand, he will control the bottle with the other hand. By touching the preterm's nipple to the preterm's lips, the preterm will be prepared for feeding, and the bottle will be placed in the baby's mouth with the mouth opening and the tongue lowering. During feeding, stimulating movements such as pushing the bottle back and forth in the mouth, which will lead the newborn to suck faster, will not be made.
No Intervention: Bottle-feeding group
Preterm infants in this group are fed with their mother's milk in the bottle during their first oral feeding.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
preterm infant's weight gain
Time Frame: 30 minutes before oral feeding and 30 minutes after oral feeding is complete
It is to determine the weight gain by weighing the preterm infant with the same diaper before and after oral feeding.
30 minutes before oral feeding and 30 minutes after oral feeding is complete

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen saturation
Time Frame: 30 minutes
Oxygen saturation ≥ 90% during and just after oral feeding
30 minutes
Heart rate
Time Frame: 30 minutes
Heart rate 120-160/min during and just after oral feeding
30 minutes

Collaborators and Investigators

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

Sponsor

Istanbul University - Cerrahpasa

Investigators

  • Study Director: Duygu Gözen, Ph.D., Istanbul University - Cerrahpasa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

December 15, 2022

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

November 29, 2022

First Submitted That Met QC Criteria

December 6, 2022

First Posted (Actual)

December 14, 2022

Study Record Updates

Last Update Posted (Actual)

April 8, 2025

Last Update Submitted That Met QC Criteria

April 5, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10840098-604.01.01-E.14287

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

product manufactured in and exported from the U.S.

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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