The Effect of Oral Feeding Model With a Chronobiological Approach in Neonates

February 10, 2025 updated by: ebru temizsoy, Istanbul Bilgi University

The Effect of Chronobiological Feeding Model on Sleep and Physiological Conditions of Neonates: A Randomized Controlled Study"

The ideal food for healthy term babies as well as preterm babies and sick term babies is breast milk. There are many studies showing that the composition of breast milk can vary from mother to mother, according to the baby's gestational age and gender. New studies on the content of breast milk suggest that breast milk is different during the day and at night, that micro and macronutrient content, hormones and some enzymes are secreted at different levels at different times of the day and that breast milk has a circadian rhythm.

This study was designed as a prospective, randomized, controlled study. The study will be conducted to evaluate the effect of the Chronobiological Approach Feeding Model application on the baby's sleep characteristics and physiological conditions in preterm babies hospitalized in the Neonatal Intensive Care Unit (NICU).

The simple randomization method will be used in the study and the babies will be divided into intervention (n=30) and control (n=30) groups. The study was conducted with 60 infants followed in the neonatal intensive care unit.

The milk of the intervention group patients will be given to the babies by matching them circadianly , while the milk of the control group patients will be given without matching according to clinical routine practice. Demographic data and sleep measurements (time and quality) of all infants will be recorded in the "Baby Monitoring Form" created by the researcher.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Circadian fluctuations in breast milk content are very important in preterm infants fed with breast milk. The composition of breast milk changes throughout the day. There is no randomized controlled study in the literature suggesting that breast milk should be matched to the infant's circadian. This study aimed to evaluate the effect of the Chronobiological Nutrition Model application on the sleep characteristics and physiological conditions of preterm infants in the neonatal intensive care unit. It is aimed to increase the sleep duration and depth of infants, shorten the crying periods and increase the quality of nursing practices by circadian matching with breast milk in the feeding of preterm infants.

Study Type

Interventional

Enrollment (Actual)

60

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
      • Sisli, Istanbul, Turkey, 34387
        • Istanbul Bilgi University

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

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Infants with family consent,
  • 32 0/6 - 36 6/7 weeks of gestation,
  • Exclusively breastfed,
  • Infants who have switched to full oral feeding

Exclusion Criteria:

  • Intravenous fluid therapy,
  • Feeding intolerance
  • Sepsis, Necrotizing enterocolitis, Major congenital anomaly,
  • Mechanical ventilation support.

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
Intervention / Treatment
No Intervention: Control group
No Intervention: Control Group Preterm infants in the NICU are fed with breast milk and bottles. Although the date is written on the expressed breast milk, it is usually not given after checking the time of day. The experiment is about labeling the breast milk according to the time of day before giving it to the babies. No extra intervention is made during feeding. The breast milk of the control group patients will be given without being matched according to the clinical routine practice. Demographic data, measurements of sleep characteristics (time and quality), and characteristics of physiological status will be recorded on the "Baby Monitoring Form" created by the researcher.
Experimental: Intervention Group
Experimental: Chronobiological Approach Nutrition Model Preterm infants in NICU are fed with breast milk and bottle. Although the date is written on expressed breast milk, it is usually not given by checking its suitability for the time of day. The milk of the intervention group patients will be matched circadian and given to the babies. Intervention group's breast milk is labeling by time of day before the each feeding. In the intervention group, a label containing the time of expressed breastmilk will be affixed. Circadian matched milk will be provided at each feeding. intervention is;n the intervention group, a label containing the time of expressed breastmilk will be affixed. In the milk preparation room, breast milk will be stored in a separate refrigerator as 08:00-19:59 day milk and 20:00-07:59 night milk. Demographic data, measurements of sleep characteristics (duration and quality), and characteristics of physiological status will be recorded on the "Baby Monitoring Form"
Procedure: Chronobiological Group
In the intervention group, a label containing the time of expressed breastmilk will be affixed. In the milk preparation room, breast milk will be stored in a separate refrigerator as 08:00-19:59 day milk and 20:00-07:59 night milk.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep time
Time Frame: 24 hour
Effect of Chronobiological Approach Feeding Model on infant sleep time during circadian matched breastfeeding sleep time in hours
24 hour
Crying time
Time Frame: 24 hour
Effect of Chronobiological Approach Feeding Model on infant crying duration measured during circadian matched breastfeeding crying duration in hours
24 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discharge time
Time Frame: through study completion, an average of 30 days]
The effect of Chronobiological Approach Nutrition Model application on infant's hospital stay
through study completion, an average of 30 days]

Collaborators and Investigators

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

Sponsor

Istanbul Bilgi University

Investigators

  • Principal Investigator: ebru temizsoy, PhD, Istanbul Bilgi 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)

December 20, 2023

Primary Completion (Actual)

December 20, 2023

Study Completion (Actual)

May 15, 2024

Study Registration Dates

First Submitted

February 6, 2025

First Submitted That Met QC Criteria

February 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 10, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/0161

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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