The Effect of Incubator Covers on the Sleep-wake Cycles of Newborn Babies: A Randomized Controlled Study

NCT07128173 | Completed

• 1 other identifier: YBozokU
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigated the effect of incubator covers on sleep-wakefulness in premature infants.The study was conducted using a randomised controlled experimental design. The study population consisted of premature in the 30-37 gestational week range who were admitted to the NICU of a hospital located in the Central Anatolia Region. The sample comprised 64 premature infants, who were divided into an incubator cover group (n = 32) and a control group (n = 32). Data were collected using a neonatal follow-up form and actigraphy. The incubator cover group received a 24-hour covers application. The control group received routine nursing care without any additional interventions. Pre-test and post-test assessments were conducted in both groups, and the 24-hour sleep patterns of the newborns were evaluated using actigraphy.

Conditions

Preterm Infants; Sleep

Keywords

Newborn; incubator cover; sleep,; wakefulness

Outcome Measures

Primary Outcomes (8)

• Sleep efficiency (pre-test)

  sleep parametres

  Actigraphy and 24-hour sleep duration were recorded before incubator cover application (pre-test)

• Sleep duration minutes (pre-test)

  sleep parametres

  24-hour sleep durations were recorded again by actigraphy (pre-test)

• Number of awakenings of the infant during sleep (pre-test)

  sleep parametres

  Actigraphy and 24-hour sleep duration were recorded before incubator cover application (pre-test)

• Wakefulness time minutes (pre-test)

  sleep parametres

  Actigraphy and 24-hour sleep duration were recorded before incubator cover application (pre-test)

• Sleep efficiency (post-test)

  sleep parametres

  Actigraphy and 24-hour sleep duration were recorded before incubator cover application (post-test)

• Sleep duration minutes (post-test)

  sleep parametres

  Actigraphy and 24-hour sleep duration were recorded before incubator cover application (post-test)

• Number of awakenings of the infant during sleep (post-test)

  sleep parametres

  Actigraphy and 24-hour sleep duration were recorded before incubator cover application (post-test)

• Wakefulness time minutes (post-test)

  sleep parametres

  Actigraphy and 24-hour sleep duration were recorded before incubator cover application (post-test)

Study Arms (2)

Incubator Cover Group

EXPERIMENTAL

Neonatal information form was filled and consent was obtained. Actigraphy and 24-hour sleep duration were recorded before incubator cover application. The incubators were covered with incubator covers for 24 hours.24-hour sleep durations were recorded again by actigraphy.

Other: Incubator Cover Group

Control Group

EXPERIMENTAL

Neonatal information form was filled and consent was obtained. Actigraphy and 24-hour sleep duration were recorded.No practice other than routine medical treatment follow-up and nursing care was performed.24-hour sleep durations were recorded again by actigraphy.

Other: Control Group

Interventions

Incubator Cover Group OTHER

Incubator Cover Group: Neonatal information form was filled and consent was obtained. Actigraphy and 24-hour sleep duration were recorded before incubator cover application.The incubators were covered with incubator covers for 24 hours.24-hour sleep durations were recorded again by actigraphy.

Incubator Cover Group

Control Group OTHER

Control Group:Neonatal information form was filled and consent was obtained. Actigraphy and 24-hour sleep duration were recorded. No practice other than routine medical treatment follow-up and nursing care was performed.24-hour sleep durations were recorded again by actigraphy.

Control Group

Eligibility Criteria

• Age: 30 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Newborn babies in the Neonatal Intensive Care Unit who were born at 30-37 weeks of gestation.
• A birth weight of 1500 grams or more. Stable vital signs
• Corrected gestational age of 30-37 weeks (plus 7-10 days). Those between 7 and 10 days old

You may not qualify if:

• Those requiring high-frequency mechanical ventilation.
• Those receiving sedative treatment.
• Those with hyperbilirubinemia
• Infants with hypoglycaemia or hyperglycaemia

Sponsors & Collaborators

• Bozok University: lead

Study Sites (1)

Yozgat Bozok University

Yozgat, Turkey (Türkiye)

Location

Related Publications (6)

• Kok EY, Kaur S, Mohd Shukri NH, Abdul Razak N, Takahashi M, Teoh SC, Tay JEF, Shibata S. The role of light exposure in infant circadian rhythm establishment: A scoping review perspective. Eur J Pediatr. 2024 Dec 30;184(1):112. doi: 10.1007/s00431-024-05951-3.

  PMID: 39738921 BACKGROUND

• Kuhn P, Zores C, Langlet C, Escande B, Astruc D, Dufour A. Moderate acoustic changes can disrupt the sleep of very preterm infants in their incubators. Acta Paediatr. 2013 Oct;102(10):949-54. doi: 10.1111/apa.12330. Epub 2013 Jul 19.

  PMID: 23800026 BACKGROUND

• Lewis P, Wild U, Pillow JJ, Foster RG, Erren TC. A systematic review of chronobiology for neonatal care units: What we know and what we should consider. Sleep Med Rev. 2024 Feb;73:101872. doi: 10.1016/j.smrv.2023.101872. Epub 2023 Nov 8.

  PMID: 38000120 BACKGROUND

• Neukamm AC, Quante M, Poets CF, Shellhaas RA; "Neonatal Sleep Talks (NEST)" group. The impact of sleep in high-risk infants. Pediatr Res. 2025 Dec;98(6):2073-2081. doi: 10.1038/s41390-025-04049-2. Epub 2025 Apr 10.

  PMID: 40210954 BACKGROUND

• Orsi KC, Avena MJ, Lurdes de Cacia Pradella-Hallinan M, da Luz Goncalves Pedreira M, Tsunemi MH, Machado Avelar AF, Pinheiro EM. Effects of Handling and Environment on Preterm Newborns Sleeping in Incubators. J Obstet Gynecol Neonatal Nurs. 2017 Mar-Apr;46(2):238-247. doi: 10.1016/j.jogn.2016.09.005. Epub 2017 Jan 3.

  PMID: 28056335 BACKGROUND

• Zores C, Dufour A, Pebayle T, Dahan I, Astruc D, Kuhn P. Observational study found that even small variations in light can wake up very preterm infants in a neonatal intensive care unit. Acta Paediatr. 2018 Jul;107(7):1191-1197. doi: 10.1111/apa.14261. Epub 2018 Feb 27.

  PMID: 29412484 BACKGROUND

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ayşe Belpınar, pHD

  Bozok University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: This study was conducted as a randomised controlled experimental study with single-blind methodology.

Study Record Dates

• First Submitted: August 10, 2025
• First Posted: August 17, 2025
• Study Start: October 15, 2023
• Primary Completion: March 15, 2024
• Study Completion: March 30, 2024
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)