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

NCT06883903 | Completed

• 1 other identifier: NEHİR ULU ÖĞÜT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Full Enteral Nutrition; the Day and Night Cycle

Keywords

Preterm; Oropharyngeal Colostrum; Day-Night Cycle; Full Enteral Nutrition; Circadian Rhythm

Outcome Measures

Primary Outcomes (1)

• Light Meter/Photometer

  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 Outcomes (2)

• Patient Information Questionnaire

  baseline

• Patient Follow-up questionnaire

  14 days, 08.00 am - 20.00 pm

Study Arms (2)

day-night cycle application

EXPERIMENTAL

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

routine practice

ACTIVE COMPARATOR

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

Interventions

day-night cycle application OTHER

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).

day-night cycle application

routine practice OTHER

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.

routine practice

Eligibility Criteria

• Age: 28 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• Biruni University: lead

Study Sites (1)

Biruni Üniversitesi

Istanbul, Zeytinburnu, 34025, Turkey (Türkiye)

Location

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MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: NURSE

Model Details: In this study, there are two groups, experimental and control. The experimental group was given a white incubator cover with a white floor, which is routinely used in the daytime unit to create a day/night cycle. , dark colored incubator cover was used at night, while the control group received a white incubator with a white floor, which is routinely used in the day/night unit. covers were used.

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 19, 2025
• Study Start: May 1, 2022
• Primary Completion: August 22, 2022
• Study Completion: December 22, 2022
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)