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 range28 Weeks – 37 Weeks

SexALL

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;
✕. Those who need to take muscle relaxants, sedatives or bronchodilators

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

Preterm Infants' Sleep- sleep log -T4

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 range28 Weeks – 37 Weeks

SexALL

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;
✕. Those who need to take muscle relaxants, sedatives or bronchodilators

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

Preterm Infants' Sleep- sleep log -T4