Preterm InfantsNCT07128173
The Effect of Incubator Covers on the Sleep-wake Cycles of Newborn Babies: A Randomized Controlled Study
A study testing Incubator Cover Group in people with Preterm Infants and Sleep, run by Bozok University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Preterm Infants, Sleep
- What is being tested?
- Incubator Cover Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2023to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Those requiring high-frequency mechanical ventilation.
- Those receiving sedative treatment.
- Those with hyperbilirubinemia
- Infants with hypoglycaemia or hyperglycaemia
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Objective: This study investigated the effect of incubator covers on sleep-wakefulness in premature infants.
Materials and Methods: 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
- Being tested
- Incubator Cover Group, Control Group
- Keywords
- Newborn, incubator cover, sleep,, wakefulness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incubator Cover GroupOther
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.
Control GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep efficiency (pre-test)
sleep parametres
Measured: Actigraphy and 24-hour sleep duration were recorded before incubator cover application (pre-test)
Sleep duration minutes (pre-test)
sleep parametres
Measured: 24-hour sleep durations were recorded again by actigraphy (pre-test)
Number of awakenings of the infant during sleep (pre-test)
sleep parametres
Measured: Actigraphy and 24-hour sleep duration were recorded before incubator cover application (pre-test)
Wakefulness time minutes (pre-test)
sleep parametres
Measured: Actigraphy and 24-hour sleep duration were recorded before incubator cover application (pre-test)
Sleep efficiency (post-test)
sleep parametres
Measured: Actigraphy and 24-hour sleep duration were recorded before incubator cover application (post-test)
Sleep duration minutes (post-test)
sleep parametres
Measured: 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
Measured: Actigraphy and 24-hour sleep duration were recorded before incubator cover application (post-test)
Wakefulness time minutes (post-test)
sleep parametres
Measured: Actigraphy and 24-hour sleep duration were recorded before incubator cover application (post-test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start15 Oct 2023
- Primary completion15 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Preterm InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was conducted as a randomised controlled experimental study with single-blind methodology.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozok University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Belpınar, Bozok University
- Investigators
- Ayşe Belpınar, pHD, Principal investigator, Bozok University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07128173
- Sponsor's protocol ID
- YBozokU
- Status last verified
- Aug 2025
- First submitted
- 10 Aug 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39738921Kuhn 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.
PubMed 23800026Lewis 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.
PubMed 38000120Neukamm 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.
PubMed 40210954Orsi 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.
PubMed 28056335Zores 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.
PubMed 29412484
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Incubator Covers on the Sleep-wake Cycles of Newborn Babies: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07128173
- Acronym / sponsor ID
- YBozokU
- Conditions
- Preterm Infants, Sleep
- Keywords
- Newborn, incubator cover, sleep,, wakefulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Bozok UniversityUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objective: This study investigated the effect of incubator covers on sleep-wakefulness in premature infants.
Materials and Methods: 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study was conducted as a randomised controlled experimental study with single-blind methodology.
| Arm | Type | Receives |
|---|---|---|
| Incubator Cover Group | Experimental | Other: Incubator Cover GroupNeonatal 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. |
| Control Group | Experimental | Other: Control GroupNeonatal 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. |
Who may qualify
- Ages
- 30 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Those requiring high-frequency mechanical ventilation.
- Those receiving sedative treatment.
- Those with hyperbilirubinemia
- Infants with hypoglycaemia or hyperglycaemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incubator Cover GroupIncubator 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. | Other | Incubator Cover Group |
| Control GroupControl 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. | Other | Control Group |
Primary outcome
Sleep efficiency (pre-test)
Time frame: Actigraphy and 24-hour sleep duration were recorded before incubator cover application (pre-test)
sleep parametres
Sleep duration minutes (pre-test)
Time frame: 24-hour sleep durations were recorded again by actigraphy (pre-test)
sleep parametres
Number of awakenings of the infant during sleep (pre-test)
Time frame: Actigraphy and 24-hour sleep duration were recorded before incubator cover application (pre-test)
sleep parametres
Wakefulness time minutes (pre-test)
Time frame: Actigraphy and 24-hour sleep duration were recorded before incubator cover application (pre-test)
sleep parametres
Sleep efficiency (post-test)
Time frame: Actigraphy and 24-hour sleep duration were recorded before incubator cover application (post-test)
sleep parametres
Sleep duration minutes (post-test)
Time frame: Actigraphy and 24-hour sleep duration were recorded before incubator cover application (post-test)
sleep parametres
Number of awakenings of the infant during sleep (post-test)
Time frame: Actigraphy and 24-hour sleep duration were recorded before incubator cover application (post-test)
sleep parametres
Wakefulness time minutes (post-test)
Time frame: Actigraphy and 24-hour sleep duration were recorded before incubator cover application (post-test)
sleep parametres
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Background: PubMed 39738921Kok 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.
- Background: PubMed 23800026Kuhn 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.
- Background: PubMed 38000120Lewis 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.
- Background: PubMed 40210954Neukamm 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.
- Background: PubMed 28056335Orsi 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.
- Background: PubMed 29412484Zores 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayşe Belpınar, pHD principal investigator
Bozok University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incubator Cover Group in people with Preterm Infants and Sleep, run by Bozok University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep efficiency (pre-test) (time frame: Actigraphy and 24-hour sleep duration were recorded before incubator cover application (pre-test)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07128173, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.