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The Effect of Cycled Light on Premature Infants and Mothers

Primary Purpose

Preterm Infant Development, Retinopathy of Prematurity, Sleep Quality

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Cycled light Experimental
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preterm Infant Development focused on measuring Cycled light, retinopathy of prematurity

Eligibility Criteria

32 Weeks - 40 Weeks (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cycled Light

Dim light

Arm Description

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.

no intervention

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Length of stay in days
Effect of light intervention in premature infants on length of stay.
Weight change
Effect of light intervention in premature infants on weight (kilograms).
Severity of retinopathy of prematurity (ROP)
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.

Full Information

First Posted
July 1, 2021
Last Updated
August 10, 2021
Sponsor
National Taiwan University Hospital
Collaborators
Taiwan Nurses Association
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1. Study Identification

Unique Protocol Identification Number
NCT05010252
Brief Title
The Effect of Cycled Light on Premature Infants and Mothers
Official Title
The Effect of Cycled Light on the Physiological and Visual Development of Premature Infants and the Mother's Sleep and Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 16, 2021 (Actual)
Primary Completion Date
February 2022 (Anticipated)
Study Completion Date
February 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
Taiwan Nurses Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infant Development, Retinopathy of Prematurity, Sleep Quality, Quality of Life
Keywords
Cycled light, retinopathy of prematurity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cycled Light
Arm Type
Experimental
Arm Description
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.
Arm Title
Dim light
Arm Type
No Intervention
Arm Description
no intervention
Intervention Type
Behavioral
Intervention Name(s)
Cycled light Experimental
Other Intervention Name(s)
Control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in mean daily Heart Rate during the intervention
Description
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.
Time Frame
up to 42 days
Title
Changes in mean Respiratory Rate during the intervention
Description
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.
Time Frame
up to 42 days
Title
Changes in mean daily oxygen saturation during the intervention
Description
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.
Time Frame
up to 42 days
Title
Changes in daily body weight during the intervention
Description
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.
Time Frame
up to 42 days
Title
Mother's sleep quality assessed by the CPSQI [followed by its scale information in the Description]
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.
Time Frame
O1 (before intervention); O2 (at the sixth week after birth); O3 (at the third month after birth)
Title
Mother's quality of life assessed by the WHOQoL-BREF [followed by its scale information in the Description]
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.
Time Frame
O1 (before intervention); O2 (at the sixth week after birth); O3 (at the third month after birth)
Secondary Outcome Measure Information:
Title
Length of stay in days
Description
Effect of light intervention in premature infants on length of stay.
Time Frame
at hospital discharge from 0 to 42 days
Title
Weight change
Description
Effect of light intervention in premature infants on weight (kilograms).
Time Frame
O1 (before intervention); O2 (at the sixth week after birth); O3 (at the third month after birth)
Title
Severity of retinopathy of prematurity (ROP)
Description
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.
Time Frame
O1 (before intervention); O2 (at the sixth week after birth); O3 (at the third month after birth)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
32 Weeks
Maximum Age & Unit of Time
40 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shin Fen Lee, Head Nurse
Phone
+886972653192
Email
007651@ntuh.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shin Fen Lee, Head Nurse
Organizational Affiliation
National Taiwan University Children Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ciao-Lin Ho, PhD
Organizational Affiliation
Second Degree Bachelor of Science in Nursing, College of Medicine, National Taiwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin-Fen Lee, Head Nurse
Phone
+886972653192
Email
007651@ntuh.gov.tw

12. IPD Sharing Statement

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The Effect of Cycled Light on Premature Infants and Mothers

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