Clinical trial NCT05010252: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Preterm Infant Development
Retinopathy of Prematurity
Sleep Quality
Quality of Life
Keywords: Cycled light
retinopathy of prematurity
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Taiwan Nurses Association
First posted: 2021-08-18
Enrollment: 320
Sex: ALL
Minimum age (years): 32
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changes in mean daily Heart Rate during the intervention
timeFrame: up to 42 days
measure: Changes in mean Respiratory Rate during the intervention
timeFrame: up to 42 days
measure: Changes in mean daily oxygen saturation during the intervention
timeFrame: up to 42 days
measure: Changes in daily body weight during the intervention
timeFrame: up to 42 days
measure: Mother's sleep quality assessed by the CPSQI [followed by its scale information in the Description]
timeFrame: O1 (before intervention); O2 (at the sixth week after birth); O3 (at the third month after birth)
measure: Mother's quality of life assessed by the WHOQoL-BREF [followed by its scale information in the Description]
timeFrame: O1 (before intervention); O2 (at the sixth week after birth); O3 (at the third month after birth)
Secondary outcomes:
measure: Length of stay in days
timeFrame: at hospital discharge from 0 to 42 days
measure: Weight change
timeFrame: O1 (before intervention); O2 (at the sixth week after birth); O3 (at the third month after birth)
measure: Severity of retinopathy of prematurity (ROP)
timeFrame: O1 (before intervention); O2 (at the sixth week after birth); O3 (at the third month after birth)
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Children Hospital
name: Shin Fen Lee, Head Nurse
role: PRINCIPAL_INVESTIGATOR
affiliation: Second Degree Bachelor of Science in Nursing, College of Medicine, National Taiwan University
name: Ciao-Lin Ho, PhD
role: PRINCIPAL_INVESTIGATOR
References: