The Effect of Day-Night Cycle on the Transition Time to Full Enteral Feeding in Preterm Newborns Receiving Oropharyngeal Colostrum (PRETERM)

March 21, 2025 updated by: NEHİR ULU ÖGÜT, Biruni University

The aim of this study was to examine the effect of the day-night cycle on the transition time to full enteral nutrition in premature infants receiving oropharyngeal colostrum. The study was conducted with a randomized controlled experimental design to test the potential of an environment that supports the biological rhythms of premature infants to improve feeding processes.

The study was conducted on 60 premature infants born at 28-32 weeks of gestation. Infants were randomly assigned to experimental and control groups, and dark-colored covers were used to create a day-night cycle in the experimental group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study was conducted to determine the effect of day-night cycle on the transition of premature newborns receiving oropharyngeal colostrum to full enteral nutrition. The data of the study, which was conducted in a randomized controlled experimental research design between May and December 2022, were collected in the Neonatology Clinic of a university-affiliated training and research hospital in Istanbul after ethical permissions were obtained. The Neonatology Clinic is a level three Neonatal Intensive Care Unit (NICU) and has the capacity to provide specialized care for premature infants.

Sample selection was done using the randomization software at https://www.randomizer.org. As a result of randomization, 30 babies were included in the experimental group and 30 babies were included in the control group. The sample size was calculated using the G*Power 3.1 program, taking into account the findings of similar studies. As a result of this calculation, at least 28 infants were needed for each group and 30 infants were included in both groups, taking into account case losses. Data were obtained from 60 premature newborns who were hospitalized in the Neonatal Intensive Care Unit at 28-32 weeks of gestation and met the inclusion criteria.

The dependent variables of the study were: time to complete enteral nutrition, physiologic parameters (heart rate, oxygen saturation, respiratory rate), discharge time and discharge weight. The independent variable of the study is the day-night cycle established in the Neonatal Intensive Care Unit.

Inclusion Criteria:

Those born between 28-32 weeks of gestation. Infants of parents who agreed to participate in the study. Major congenital anomaly, severe systemic disease, presence of necrotizing enterocolitis, presence of suspected or confirmed sepsis, birth asphyxia (newborns with cord pH/29 arterial pH <7.0).

Newborns admitted to the NICU at ≤ 24 hours of age.

Exclusion Criteria:

Infants excluded from the inclusion criteria for this study Data Collection Forms In the data collection process, Patient Information Form including demographic and clinical information of premature newborns and Patient Monitoring Charts were used to monitor physiologic parameters during the study. In addition, a Voluntary Consent Form was used to obtain written consent from the parents.

Data Collection Tools

The devices used in the study are as follows:

Philips Intellivue MP50 Bedside Monitor: This device was used to measure heart rate, oxygen saturation and respiratory rate of premature infants.

DragerGiraffe Incubator: These are double-walled, digital weighing incubators used to monitor babies in the NICU. These incubators provide a stable environment by preventing the baby from losing heat.

Smart Sensor AS803 DigitalLuxMeter: It was used to measure the light level in the incubator head. Light level control for the babies in the experimental group was provided with this device.

Incubator Covers: Dark colored (navy blue) covers were used in the experimental group to support the day-night cycle. In the control group, standard white covers were used.

Data Collection The families of the premature infants to be included in the study were informed about the purpose, content and method of the study and their written informed consent was obtained. Newborns in both groups were administered 0.1 ml colostrum into the right and left buccal oral cavity at 3-hour intervals for 14 days. In the experimental group, a 12-hour day-night cycle was established with a white incubator cover during the day and a dark colored incubator cover at night. Physiologic parameters of the infants were recorded with monitors before and after the application. In the experimental group, a day-night cycle was achieved by using dark colored covers for the night, while standard white covers were used in the control group.

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
    • Zeytinburnu
      • Istanbul, Zeytinburnu, Turkey, 34025
        • Biruni Üniversitesi

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

No

Description

Inclusion Criteria:

  • Those born between 28-32 weeks of gestation.
  • Infants of parents who agreed to participate in the study.
  • Major congenital anomaly, severe systemic disease, necrotizing enterocolitis presence, presence of suspected or confirmed sepsis, birth asphyxia (cord pH / 29 Newborns without arterial pH <7.0).
  • Neonates admitted to the NICU at ≤ 24 hours of age.

Exclusion Criteria:

  • babies excluded from the inclusion criteria for this study

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: day-night cycle application
In this group, colostrum delivered to the unit within the first 5 days of life was administered by the nurse every three hours for 14 days. In order to create a day/night cycle, a white incubator cover was used routinely in the unit during the day (between 08.00-20.00 hours) and a dark colored incubator cover was used at night (between 20.00-08.00 hours).
Other: day-night cycle application
In this group, colostrum delivered to the unit within the first 5 days of life was administered by the nurse every three hours for 14 days. In order to create a day/night cycle, a white incubator cover was used routinely in the unit during the day (between 08.00-20.00 hours) and a dark colored incubator cover was used at night (between 20.00-08.00 hours).
Active Comparator: routine practice

In this group, colostrum delivered to the unit within the first 5 days of life was administered every three hours for 14 days by the nurse.

is the group whose covers are used.
Other: routine practice

In this group, colostrum delivered to the unit within the first 5 days of life was administered every three hours for 14 days by the nurse.

is the group whose covers are used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Light Meter/Photometer
Time Frame: 14 days, 08.00 am - 20.00 pm
light source in the neonatal intensive care unit and the area illuminated by the source illumination power analyzes between the Smart Sensor AS803 Digital It is done with Lux Meter device. In the NICU, the lowest light level at the beginning of each incubator 10 lux should be configured with a maximum of 600 lux. The light intensity measured in the incubator in the unit varied between 15 and 40 lx.
14 days, 08.00 am - 20.00 pm

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Information Questionnaire
Time Frame: baseline
In the questionnaire prepared to determine the demographic characteristics of premature newborns, questions such as gender, gestational week, mode of delivery, birth weight, hospitalization diagnosis and postnatal age were included. However, it is not a scale.
baseline
Patient Follow-up questionnaire
Time Frame: 14 days, 08.00 am - 20.00 pm
It is a form in which respiratory support status, feeding type, type of food taken, IV fluids given, daily fluid intake/ml, transition to full enteral nutrition are recorded in premature newborns, but it is not a scal
14 days, 08.00 am - 20.00 pm

Collaborators and Investigators

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

Sponsor

Biruni University

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

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)

May 1, 2022

Primary Completion (Actual)

August 22, 2022

Study Completion (Actual)

December 22, 2022

Study Registration Dates

First Submitted

February 24, 2025

First Submitted That Met QC Criteria

March 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 26, 2025

Last Update Submitted That Met QC Criteria

March 21, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEHİR ULU ÖĞÜT

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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