The Effect of Cycled Light on Premature Infants and Mothers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-16

Study Completion Date

2022-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Preterm Infants: Light Effects on Health and Development

NCT02146287

Preterm Infant Health Preterm Infant Development

COMPLETED NA

Cycled Light and Crying of Preterm Infants

NCT01513226

Crying Sleep

COMPLETED NA

Compare of Effectiveness Cycled Light or Near Darkness on Growth Parameters in Preterm Infants

NCT02088359

Compare of Effectiveness Cycled Light and Near Darkness on Growth in Preterm Infants

COMPLETED

Effect of Reduced Noise Levels and Cycled Light on Visual and Neural Development in Preterm Infants

NCT02688010

Preterm Infants

COMPLETED NA

Sleep Program on Preterm Infants' Sleep, and Caregiver's Sleep, Stress, Quality of Life, and Attachment

NCT04932044

Preterm Infants Sleep Quality of Life

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Preterm Infant Development Retinopathy of Prematurity Sleep Quality Quality of Life

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Cycled light Experimental

Intervention Type 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.

Dim light

no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Control group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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.

Minimum Eligible Age

32 Weeks

Maximum Eligible Age

40 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes