The Effect of Cycled Light on Premature Infants and Mothers

NCT05010252 | Unknown

• 1 other identifier: 202012022RIND
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

Irregular lighting and lack of light in premature infants will affect their health, produce negative effects such as physiological and visual development, and also affect the mother's sleep and quality of life. This study is to verify the effect and delay effect of two-week premature infants' light intervention on their physiological indicators and visual development, mother's sleep quality and quality of life. It is planned to be in the Neonatal Moderate to Severe Ward of National Taiwan University Children's Hospital, and the subjects are premature babies born 32 weeks old. Divided into two groups of light intervention group and control group, longitudinal tracking intervention effect and six-week and three-month delay effect.

Conditions

Preterm Infant Development; Retinopathy of Prematurity; Sleep Quality; Quality of Life

Keywords

Cycled light; retinopathy of prematurity

Outcome Measures

Primary Outcomes (6)

• Changes in mean daily Heart Rate during the intervention

  This is to evaluate the effect of cycled light intervention on Heart Rate (beats/min) in preterm infants. Heart Rate is recorded every 5 minutes. Take the daily average of the Heart Rate, and then analyze its daily change before discharge. The intervention time is after the parents of premature infants agree to participate and before premature infants are discharged from the hospital.

  up to 42 days

• Changes in mean Respiratory Rate during the intervention

  This is to evaluate the effect of cycled light intervention on Respiratory Rate (breaths/min) in preterm infants. Respiratory Rate is recorded every 5 minutes. Take the daily average of the Respiratory Rate, and then analyze its daily change before discharge. The intervention time is after the parents of premature infants agree to participate and before premature infants are discharged from the hospital.

  up to 42 days

• Changes in mean daily oxygen saturation during the intervention

  This is to evaluate the effect of cycled light intervention on oxygen saturation SpO2 (%) in preterm infants. Oxygen saturation SpO2 is recorded every 5 minutes. Take the daily average of the oxygen saturation SpO2, and then analyze its daily change before discharge. The intervention time is after the parents of premature infants agree to participate and before premature infants are discharged from the hospital.

  up to 42 days

• Changes in daily body weight during the intervention

  This is to evaluate the effect of cycled light intervention on body weight (kilograms) in preterm infants. Body weight is recorded every day during hospital stay after intervention, and then we analyze its daily change before discharge. The intervention time is after the parents of premature infants agree to participate and before premature infants are discharged from the hospital.

  up to 42 days

• Mother's sleep quality assessed by the CPSQI [followed by its scale information in the Description]

  Measured by Pittsburgh Sleep Quality Index (CPSQI). Effect of light intervention in premature infants on mother's sleep quality. Data will be collected for the first time (O1) before the experiment, post-test (O2) will be performed six weeks after the intervention, and post-test (O3) will be performed three months after the intervention.

  O1 (before intervention); O2 (at the sixth week after birth); O3 (at the third month after birth)

• Mother's quality of life assessed by the WHOQoL-BREF [followed by its scale information in the Description]

  The measurement was conducted by the World Health Organization Quality of Life Brief (WHOQoL-BREF) questionnaire. Effect of light intervention in premature infants on mother's quality of life. Data will be collected for the first time (O1) before the experiment, post-test (O2) will be performed six weeks after the intervention, and post-test (O3) will be performed three months after the intervention.

  O1 (before intervention); O2 (at the sixth week after birth); O3 (at the third month after birth)

Secondary Outcomes (3)

• Length of stay in days

  at hospital discharge from 0 to 42 days

• Weight change

  O1 (before intervention); O2 (at the sixth week after birth); O3 (at the third month after birth)

• Severity of retinopathy of prematurity (ROP)

  O1 (before intervention); O2 (at the sixth week after birth); O3 (at the third month after birth)

Study Arms (2)

Cycled Light

EXPERIMENTAL

It is planned to be in the Neonatal Intermediate Care Nursery, National Taiwan University Children's Hospital, and the subjects are premature babies over 32 weeks old. Divided into two groups of light intervention group and control group, longitudinal tracking intervention effect and six-weeks and three-months delay effect.

Behavioral: Cycled light Experimental

Dim light

NO INTERVENTION

no intervention

Interventions

Cycled light Experimental BEHAVIORAL

The preliminary plan of this study is to carry out empirical evidence and expert advice to confirm precise lighting and develop care intervention strategies for preterm infants based on evidence. It is planned to be in the Neonatal Intermediate Care Nursery, National Taiwan University Children's Hospital, and the subjects are premature babies born 32 weeks old. Divided into two groups of light intervention group and control group, longitudinal tracking intervention effect and six-weeks and three-months delay effect.

Also known as: Control group

Cycled Light

Eligibility Criteria

• Age: 32 Weeks - 40 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Taiwan Nurses Association: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Related Publications (1)

• Morag I, Xiao YT, Bruschettini M. Cycled light in the intensive care unit for preterm and low birth weight infants. Cochrane Database Syst Rev. 2024 Dec 19;12(12):CD006982. doi: 10.1002/14651858.CD006982.pub5.

  PMID: 39699174 DERIVED

MeSH Terms

Conditions

Retinopathy of Prematurity; Sleep Initiation and Maintenance Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• Shin Fen Lee, Head Nurse

  National Taiwan University Children Hospital

  PRINCIPAL INVESTIGATOR

• Ciao-Lin Ho, PhD

  Second Degree Bachelor of Science in Nursing, College of Medicine, National Taiwan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shin Fen Lee, Head Nurse

CONTACT

+886972653192; 007651@ntuh.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: August 18, 2021
• Study Start: April 16, 2021
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: August 18, 2021

Record last verified: 2021-07

Locations

TW (1)