The Effect of Cycled Light on Premature Infants and Mothers

August 10, 2021 updated by: National Taiwan University Hospital

The Effect of Cycled Light on the Physiological and Visual Development of Premature Infants and the Mother's Sleep and Quality of Life

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background Dim, irregular lighting and lack of periodic light in the care environment for premature babies in Taiwan are currently common conditions. 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.

Purpose 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.

Methods 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 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.

Study Type

Interventional

Enrollment (Anticipated)

320

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 Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

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

7 months to 9 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria: (1) Premature infants over 32 weeks old, (2) Stable physiological conditions.

Exclusion criteria: (1) taking drugs that may interfere with sleep, (2) suffering from retinopathy (ROP) stage 3 or higher, (3) suffering from intracranial hemorrhage, grade 3 or higher, (4) suffering from upper limb injury or movement disorders, (5) The family has alcohol and drug abuse problems, (6) currently using respirators.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cycled Light
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
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.
Other Names:
  • Control group
No Intervention: Dim light
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in mean daily Heart Rate during the intervention
Time Frame: up to 42 days
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
Time Frame: up to 42 days
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
Time Frame: up to 42 days
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
Time Frame: up to 42 days
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]
Time Frame: O1 (before intervention); O2 (at the sixth week after birth); O3 (at the third month after birth)
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]
Time Frame: O1 (before intervention); O2 (at the sixth week after birth); O3 (at the third month after birth)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay in days
Time Frame: at hospital discharge from 0 to 42 days
Effect of light intervention in premature infants on length of stay.
at hospital discharge from 0 to 42 days
Weight change
Time Frame: O1 (before intervention); O2 (at the sixth week after birth); O3 (at the third month after birth)
Effect of light intervention in premature infants on weight (kilograms).
O1 (before intervention); O2 (at the sixth week after birth); O3 (at the third month after birth)
Severity of retinopathy of prematurity (ROP)
Time Frame: O1 (before intervention); O2 (at the sixth week after birth); O3 (at the third month after birth)
ROP is described by its location in the eye (the zone), by the severity of the disease (the stage) and by the appearance of the retinal vessels (plus disease). The first stage of ROP is a demarcation line that separates normal from premature retina. Stage 2 is a ridge which has height and width. Stage 3 is the growth of fragile new abnormal blood vessels. The severity of ROP is judged by the doctor.
O1 (before intervention); O2 (at the sixth week after birth); O3 (at the third month after birth)

Collaborators and Investigators

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

Sponsor

National Taiwan University Hospital

Collaborators

Taiwan Nurses Association, TWNA.

Investigators

  • Principal Investigator: 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

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)

April 16, 2021

Primary Completion (Anticipated)

February 1, 2022

Study Completion (Anticipated)

February 1, 2022

Study Registration Dates

First Submitted

July 1, 2021

First Submitted That Met QC Criteria

August 10, 2021

First Posted (Actual)

August 18, 2021

Study Record Updates

Last Update Posted (Actual)

August 18, 2021

Last Update Submitted That Met QC Criteria

August 10, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202012022RIND

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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