Clinical trial NCT04932044: Sleep Program on Preterm Infants' Sleep, and Caregiver's Sleep, Stress, Quality of Life, and Attachment
Official title: Construction and Longitudinal Following Up the Effects of Early Sleep Facilitation Program on Preterm Infants' Sleep, Health After Discharge, and Caregiver's Sleep, Stress, Quality of Life, and Attachment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preterm Infants
Sleep
Quality of Life
Keywords: Preterm Infants
Sleep
Quality of Life
Attachment
Actigraphy
Lead sponsor: National Defense Medical Center, Taiwan
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 70
Sex: ALL
Minimum age (years): 28
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This research plan to construct an "Early Sleep Facilitation Program"and to explore the effects of the "early sleep Facilitation program" on the sleep and health of preterm infants and the sleep, stress, quality of life and attachment of the caregiver for a Long-term follow-up research.

The proposed study has six specific aims:

1. Explore the effect of "Early Sleep Facilitation Program" on the sleep of preterm infants during hospitalization and after returning home.
2. Explore the effect of "Early Sleep Facilitation Program" on the health of preterm infants during hospitalization and after returning home.
3. Explore the effect of "Early Sleep Facilitation Program" on the sleep of the caregiver after preterm infants during hospitalization and after returning home.
4. Explore the effect of the "Early Sleep Facilitation Program" on the stress of the caregivers of preterm infants during hospitalization and after returning home.
5. Explore the effect of "Early Sleep Facilitation Program" on the quality of life of the caregivers of preterm infants during hospitalization and after returning home.
6. Explore the effect of "Early Sleep Facilitation Program" on the attachment of the caregivers of preterm infants during hospitalization and after returning home.

Detailed description: Background and purpose:

Preterm infants need to receive intensive care in a neonatal intensive care unit (NICU) to survive, but the sleep of preterm infants is disturbed by the environment of the intensive care unit, invasive treatment and care activities. When a preterm infant's sleep is interrupted, it not only affects his physical growth, behavior and emotional development, but also affects his recovery from illness and the length of hospital stay, and even affects his sleep quality and development after returning home. However, medical personnel are busy with clinical practice, seldom pay attention to the sleep development of preterm infants. In the past, few studies paid attention to the factors that affect the sleep of preterm infants after returning home, and few studies also explored the sleep and physical and mental health of preterm infants and their main caregivers after returning home. Sleep intervention in preterm infants was mostly a single outcome indicator; besides, past studies lacked objective sleep instruments and long-term follow-up studies.

Based on the above research gaps, this research plan to construct an "early sleep Facilitation program" and to explore the effects of the "Early Sleep Facilitation Program" on the sleep and health of preterm infants and the sleep, stress, quality of life and attachment of the caregiver for a Long-term follow-up research.

The proposed study has six specific aims:

1. Explore the effect of "Early Sleep Facilitation Program" on the sleep of preterm infants during hospitalization and after returning home.
2. Explore the effect of "Early Sleep Facilitation Program" on the health of preterm infants during hospitalization and after returning home.
3. Explore the effect of "Early Sleep Facilitation Program" on the sleep of the caregiver after preterm infants during hospitalization and after returning home.
4. Explore the effect of the "Early Sleep Facilitation Program" on the stress of the caregivers of preterm infants during hospitalization and after returning home.
5. Explore the effect of "Early Sleep Facilitation Program" on the quality of life of the caregivers of preterm infants during hospitalization and after returning home.
6. Explore the effect of "Early Sleep Facilitation Program" on the attachment of the caregivers of preterm infants during hospitalization and after returning home.

Methods:

This randomized controlled trial will adopt a longitudinal repeated measures design to examine the " Early Sleep Facilitation Program " on the sleep and health of preterm infants and the sleep, stress, quality of life and attachment of the caregiver. Preterm infants and the caregiver were recruited by convenience sampling in Neonatal Intensive Care Unit and Infant Intermediate Care Unit of a medical center in northern Taiwan from July in 2020 to December in 2022. There are two different intervention modes (intervention group and control group), the intervention group receives " Early Sleep Facilitation Program " and the control group receives routine care. The program is divided into two stages. The first stage is to provide sleep circadian rhythm training for preterm infants during hospitalization, and the second stage is to give the caregiver the nursing guidance to promote preterm infants' sleep before preterm infants discharged from the hospital. Moreover, continue to give nursing guidance and follow its implementation status after the first month and the second month after discharge. The control group receives routine care and provide general discharge care and nursing guidance. The questionnaires and physiological measurements will be used to collect the data. The two groups will collect data during hospitalization, one week before discharge, and the first month and the second month after discharge. We will use generalized estimation equations method to analyze research data.

Eligibility criteria: Inclusion Criteria:

1. Preterm infants gestational age (GA) \> 28 weeks and \< 37 weeks, and birth weight less than 2200 grams;
2. The main caregiver of the preterm infants can communicate in Mandarin and Taiwanese;
3. The parents of the preterm infants and their main caregivers agrees to participate in this research and signs the research consent form

Exclusion Criteria:

1. Premature infant is diagnosed with limb dysfunction or brain neuropathy, such as: third or fourth degree intraventricular hemorrhage or peripheral ventricular leukomalacia;
2. Other diseases that affect sleep, such as: congenital nerve development Abnormalities, epilepsy;
3. Those who need to take muscle relaxants, sedatives or bronchodilators

Primary outcomes:
measure: Preterm Infants' Sleep- Actigraphy -T1
timeFrame: T1-baseline collect preterm infants after 32 weeks of gestation before intervention
measure: Preterm Infants' Sleep- Actigraphy -T2
timeFrame: T2- preterm infants one week before discharge
measure: Preterm Infants' Sleep- Actigraphy -T3
timeFrame: T3- preterm infants the first month after discharge
measure: Preterm Infants' Sleep- Actigraphy -T4
timeFrame: T4- preterm infants second month after discharge
measure: Preterm Infants' Sleep- sleep log -T1
timeFrame: T1-baseline collect preterm infants after 32 weeks of gestation before intervention
measure: Preterm Infants' Sleep- sleep log -T2
timeFrame: T2- preterm infants one week before discharge
measure: Preterm Infants' Sleep- sleep log -T3
timeFrame: T3- preterm infants the first month after discharge
measure: Preterm Infants' Sleep- sleep log -T4
timeFrame: T4- preterm infants second month after discharge
measure: Preterm Infants' Health- Health Assessment Form-weight-T1
timeFrame: T1-baseline collect preterm infants after 32 weeks of gestation before intervention
measure: Preterm Infants' Health- Health Assessment Form-weight-T2
timeFrame: T2- preterm infants one week before discharge
measure: Preterm Infants' Health- Health Assessment Form-weight-T3
timeFrame: T3- preterm infants the first month after discharge
measure: Preterm Infants' Health- Health Assessment Form-weight-T4
timeFrame: T4- preterm infants second month after discharge
measure: Preterm Infants' Health- Health Assessment Form- head circumference-T1
timeFrame: T1-baseline collect preterm infants after 32 weeks of gestation before intervention
measure: Preterm Infants' Health- Health Assessment Form- head circumference-T2
timeFrame: T2- preterm infants one week before discharge
measure: Preterm Infants' Health- Health Assessment Form- head circumference-T3
timeFrame: T3- preterm infants the first month after discharge
measure: Preterm Infants' Health- Health Assessment Form- head circumference-T4
timeFrame: T4- preterm infants second month after discharge
measure: Preterm Infants' Health- Nutrition data-T1
timeFrame: T1-baseline collect preterm infants after 32 weeks of gestation before intervention
measure: Preterm Infants' Health- Nutrition data-T2
timeFrame: T2- preterm infants one week before discharge
measure: Preterm Infants' Health- Nutrition data-T3
timeFrame: T3- preterm infants the first month after discharge
measure: Preterm Infants' Health- Nutrition data-T4
timeFrame: T4- preterm infants second month after discharge
measure: Caregivers' Sleep- Actigraphy-T1
timeFrame: T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention
measure: Caregivers' Sleep- Actigraphy-T2
timeFrame: T2- preterm infants one week before discharge
measure: Caregivers' Sleep- Actigraphy-T3
timeFrame: T3- preterm infants the first month after discharge
measure: Caregivers' Sleep- Actigraphy-T4
timeFrame: T4- preterm infants second month after discharge
measure: Caregivers' Sleep- Pittsburgh Sleep Quality Index (PSQI)-T1
timeFrame: T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention
measure: Caregivers' Sleep- Pittsburgh Sleep Quality Index (PSQI)-T2
timeFrame: T2- preterm infants one week before discharge
measure: Caregivers' Sleep- Pittsburgh Sleep Quality Index (PSQI)-T3
timeFrame: T3- preterm infants the first month after discharge
measure: Caregivers' Sleep- Pittsburgh Sleep Quality Index (PSQI)-T4
timeFrame: T4- preterm infants second month after discharge
measure: Caregivers' Sleep- Sleep log-T1
timeFrame: T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention
measure: Caregivers' Sleep- Sleep log-T2
timeFrame: T2- preterm infants one week before discharge
measure: Caregivers' Sleep- Sleep log-T3
timeFrame: T3- preterm infants the first month after discharge
measure: Caregivers' Sleep- Sleep log-T4
timeFrame: T4- preterm infants second month after discharge
measure: Caregivers' Stress- T1
timeFrame: T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention
measure: Caregivers' Stress- T2
timeFrame: T2- preterm infants one week before discharge
measure: Caregivers' Stress- T3
timeFrame: T3- preterm infants the first month after discharge
measure: Caregivers' Stress- T4
timeFrame: T4- preterm infants second month after discharge
measure: Caregivers' quality of life-T1
timeFrame: T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention
measure: Caregivers' quality of life-T2
timeFrame: T2- preterm infants one week before discharge
measure: Caregivers' quality of life-T3
timeFrame: T3- preterm infants the first month after discharge
measure: Caregivers' quality of life-T4
timeFrame: T4- preterm infants second month after discharge
measure: Caregivers' attachment-T1
timeFrame: T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention
measure: Caregivers' attachment-T2
timeFrame: T2- preterm infants one week before discharge
measure: Caregivers' attachment-T3
timeFrame: T3- preterm infants the first month after discharge
measure: Caregivers' attachment-T4
timeFrame: T4- preterm infants second month after discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei city
country: Taiwan
facility: National defense medical center
Study officials:
affiliation: National Defense Medical Center, Taiwan
name: Hsiang-Yun Lan, Asst. Prof.
role: PRINCIPAL_INVESTIGATOR
References: