The Effect of Cycled Light on Premature Infants and Mothers

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05010252
Collaborator
Taiwan Nurses Association, TWNA. (Other)
320
1
2
9.6
33.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cycled light Experimental
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
320 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 16, 2021
Anticipated Primary Completion Date :
Feb 1, 2022
Anticipated Study Completion Date :
Feb 1, 2022

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Changes in mean daily Heart Rate during the intervention [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.

    2. Changes in mean Respiratory Rate during the intervention [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.

    3. Changes in mean daily oxygen saturation during the intervention [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.

    4. Changes in daily body weight during the intervention [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.

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

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

    Secondary Outcome Measures

    1. Length of stay in days [at hospital discharge from 0 to 42 days]

      Effect of light intervention in premature infants on length of stay.

    2. Weight change [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).

    3. Severity of retinopathy of prematurity (ROP) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    32 Weeks to 40 Weeks
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Taiwan University Hospital Taipei Taiwan 100

    Sponsors and Collaborators

    • National Taiwan University Hospital
    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT05010252
    Other Study ID Numbers:
    • 202012022RIND
    First Posted:
    Aug 18, 2021
    Last Update Posted:
    Aug 18, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Taiwan University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 18, 2021