CompletedNot Applicable

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

Taiwan86 participantsStarted 2020-12-01

Plain-language 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.

Who can participate

Age range

28 Weeks – 37 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

. Premature infant is diagnosed with limb dysfunction or brain neuropathy, such as: third or fourth degree intraventricular hemorrhage or peripheral ventricular leukomalacia;
. Other diseases that affect sleep, such as: congenital nerve development Abnormalities, epilepsy;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Preterm Infants' Sleep- Actigraphy -T1

Timeframe: T1-baseline collect preterm infants after 32 weeks of gestation before intervention

Preterm Infants' Sleep- Actigraphy -T2

Timeframe: T2- preterm infants one week before discharge

Preterm Infants' Sleep- Actigraphy -T3

Timeframe: T3- preterm infants the first month after discharge

Preterm Infants' Sleep- Actigraphy -T4

Timeframe: T4- preterm infants second month after discharge

Preterm Infants' Sleep- sleep log -T1

Timeframe: T1-baseline collect preterm infants after 32 weeks of gestation before intervention

Preterm Infants' Sleep- sleep log -T2

Timeframe: T2- preterm infants one week before discharge

Preterm Infants' Sleep- sleep log -T3

Timeframe: T3- preterm infants the first month after discharge

Trial details

NCT IDNCT04932044

SponsorNational Defense Medical Center, Taiwan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-01

View on ClinicalTrials.gov More Preterm Infants trials

Plain-language summary

Who can participate

Age range

28 Weeks – 37 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

. Premature infant is diagnosed with limb dysfunction or brain neuropathy, such as: third or fourth degree intraventricular hemorrhage or peripheral ventricular leukomalacia;
. Other diseases that affect sleep, such as: congenital nerve development Abnormalities, epilepsy;

What they're measuring

Preterm Infants' Sleep- Actigraphy -T1

Timeframe: T1-baseline collect preterm infants after 32 weeks of gestation before intervention

Preterm Infants' Sleep- Actigraphy -T2

Timeframe: T2- preterm infants one week before discharge

Preterm Infants' Sleep- Actigraphy -T3

Timeframe: T3- preterm infants the first month after discharge

Preterm Infants' Sleep- Actigraphy -T4

Timeframe: T4- preterm infants second month after discharge

Preterm Infants' Sleep- sleep log -T1

Timeframe: T1-baseline collect preterm infants after 32 weeks of gestation before intervention

Preterm Infants' Sleep- sleep log -T2

Timeframe: T2- preterm infants one week before discharge

Preterm Infants' Sleep- sleep log -T3

Timeframe: T3- preterm infants the first month after discharge