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

NCT04932044 | Completed

• 1 other identifier: C202005014
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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

Conditions

Preterm Infants; Sleep; Quality of Life

Keywords

Preterm Infants; Sleep; Quality of Life; Attachment; Actigraphy

Outcome Measures

Primary Outcomes (44)

• Preterm Infants' Sleep- Actigraphy -T1

  Accessed by Actigraphy

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

• Preterm Infants' Sleep- Actigraphy -T2

  Accessed by Actigraphy

  T2- preterm infants one week before discharge

• Preterm Infants' Sleep- Actigraphy -T3

  Accessed by Actigraphy

  T3- preterm infants the first month after discharge

• Preterm Infants' Sleep- Actigraphy -T4

  Accessed by Actigraphy

  T4- preterm infants second month after discharge

• Preterm Infants' Sleep- sleep log -T1

  The primary caregiver records the sleep log of premature babies. The sleep log is used to understand the total sleep hours of premature infants, the number of awake hours/times at night, sleep efficiency, and factors that may interfere with sleep.

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

• Preterm Infants' Sleep- sleep log -T2

  The primary caregiver records the sleep log of premature babies. The sleep log is used to understand the total sleep hours of premature infants, the number of awake hours/times at night, sleep efficiency, and factors that may interfere with sleep.

  T2- preterm infants one week before discharge

• Preterm Infants' Sleep- sleep log -T3

  The primary caregiver records the sleep log of premature babies. The sleep log is used to understand the total sleep hours of premature infants, the number of awake hours/times at night, sleep efficiency, and factors that may interfere with sleep.

  T3- preterm infants the first month after discharge

• Preterm Infants' Sleep- sleep log -T4

  The primary caregiver records the sleep log of premature babies. The sleep log is used to understand the total sleep hours of premature infants, the number of awake hours/times at night, sleep efficiency, and factors that may interfere with sleep.

  T4- preterm infants second month after discharge

• Preterm Infants' Health- Health Assessment Form-weight-T1

  The weight is measured by the researcher with a baby weight scale. This device record data: weight(kg). Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.

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

• Preterm Infants' Health- Health Assessment Form-weight-T2

  The weight is measured by the researcher with a baby weight scale. This device record data: weight(kg). Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.

  T2- preterm infants one week before discharge

• Preterm Infants' Health- Health Assessment Form-weight-T3

  The weight is measured by the researcher with a baby weight scale. This device record data: weight(kg). Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.

  T3- preterm infants the first month after discharge

• Preterm Infants' Health- Health Assessment Form-weight-T4

  The weight is measured by the researcher with a baby weight scale. This device record data: weight(kg). Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.

  T4- preterm infants second month after discharge

• Preterm Infants' Health- Health Assessment Form- head circumference-T1

  The head circumference is measured by the researcher with tape measure. This device record data: head circumference (cm). Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.

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

• Preterm Infants' Health- Health Assessment Form- head circumference-T2

  The head circumference is measured by the researcher with tape measure. This device record data: head circumference (cm). Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.

  T2- preterm infants one week before discharge

• Preterm Infants' Health- Health Assessment Form- head circumference-T3

  The head circumference is measured by the researcher with tape measure. This device record data: head circumference (cm). Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.

  T3- preterm infants the first month after discharge

• Preterm Infants' Health- Health Assessment Form- head circumference-T4

  The head circumference is measured by the researcher with tape measure. This device record data: head circumference (cm). Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.

  T4- preterm infants second month after discharge

• Preterm Infants' Health- Nutrition data-T1

  Data on nutrition support included: recordings of types of feeding (breast milk or formula), total fluid intakes, and number of feeding interruptions.

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

• Preterm Infants' Health- Nutrition data-T2

  Data on nutrition support included: recordings of types of feeding (breast milk or formula), total fluid intakes, and number of feeding interruptions.

  T2- preterm infants one week before discharge

• Preterm Infants' Health- Nutrition data-T3

  Data on nutrition support included: recordings of types of feeding (breast milk or formula), total fluid intakes, and number of feeding interruptions.

  T3- preterm infants the first month after discharge

• Preterm Infants' Health- Nutrition data-T4

  Data on nutrition support included: recordings of types of feeding (breast milk or formula), total fluid intakes, and number of feeding interruptions.

  T4- preterm infants second month after discharge

• Caregivers' Sleep- Actigraphy-T1

  Accessed by Actigraphy. Actigraphy is a validated method of objectively measuring sleep parameters and average motor activity.

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

• Caregivers' Sleep- Actigraphy-T2

  Accessed by Actigraphy. Actigraphy is a validated method of objectively measuring sleep parameters and average motor activity.

  T2- preterm infants one week before discharge

• Caregivers' Sleep- Actigraphy-T3

  Accessed by Actigraphy. Actigraphy is a validated method of objectively measuring sleep parameters and average motor activity.

  T3- preterm infants the first month after discharge

• Caregivers' Sleep- Actigraphy-T4

  Accessed by Actigraphy. Actigraphy is a validated method of objectively measuring sleep parameters and average motor activity.

  T4- preterm infants second month after discharge

• Caregivers' Sleep- Pittsburgh Sleep Quality Index (PSQI)-T1

  The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction.

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

• Caregivers' Sleep- Pittsburgh Sleep Quality Index (PSQI)-T2

  The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction.

  T2- preterm infants one week before discharge

• Caregivers' Sleep- Pittsburgh Sleep Quality Index (PSQI)-T3

  The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction.

  T3- preterm infants the first month after discharge

• Caregivers' Sleep- Pittsburgh Sleep Quality Index (PSQI)-T4

  The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction.

  T4- preterm infants second month after discharge

• Caregivers' Sleep- Sleep log-T1

  Sleep log: record the sleep time and sleep status of the previous day to understand the total sleep hours, the number of awake hours/times at night, sleep efficiency, and whether there are events that affect the mood of falling asleep, medication or physical discomfort, whether to consume irritating substances and alcohol, etc. And use a scale of 1 to 5 points to assess the quality of sleep the night before and the level of wakefulness when waking up.

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

• Caregivers' Sleep- Sleep log-T2

  Sleep log: record the sleep time and sleep status of the previous day to understand the total sleep hours, the number of awake hours/times at night, sleep efficiency, and whether there are events that affect the mood of falling asleep, medication or physical discomfort, whether to consume irritating substances and alcohol, etc. And use a scale of 1 to 5 points to assess the quality of sleep the night before and the level of wakefulness when waking up.

  T2- preterm infants one week before discharge

• Caregivers' Sleep- Sleep log-T3

  Sleep log: record the sleep time and sleep status of the previous day to understand the total sleep hours, the number of awake hours/times at night, sleep efficiency, and whether there are events that affect the mood of falling asleep, medication or physical discomfort, whether to consume irritating substances and alcohol, etc. And use a scale of 1 to 5 points to assess the quality of sleep the night before and the level of wakefulness when waking up.

  T3- preterm infants the first month after discharge

• Caregivers' Sleep- Sleep log-T4

  Sleep log: record the sleep time and sleep status of the previous day to understand the total sleep hours, the number of awake hours/times at night, sleep efficiency, and whether there are events that affect the mood of falling asleep, medication or physical discomfort, whether to consume irritating substances and alcohol, etc. And use a scale of 1 to 5 points to assess the quality of sleep the night before and the level of wakefulness when waking up.

  T4- preterm infants second month after discharge

• Caregivers' Stress- T1

  Parenting Stress Index-Third Edition short form (PSI-SF) The PSI Short Form is a direct derivative of the full-length test and consists of a 36-item self-scoring questionnaire/profile. Each question is based on Likert's five-point. The total score is between 36-180 points, the higher the score, the greater the parental pressure.

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

• Caregivers' Stress- T2

  Parenting Stress Index-Third Edition short form (PSI-SF) The PSI Short Form is a direct derivative of the full-length test and consists of a 36-item self-scoring questionnaire/profile. Each question is based on Likert's five-point. The total score is between 36-180 points, the higher the score, the greater the parental pressure.

  T2- preterm infants one week before discharge

• Caregivers' Stress- T3

  Parenting Stress Index-Third Edition short form (PSI-SF) The PSI Short Form is a direct derivative of the full-length test and consists of a 36-item self-scoring questionnaire/profile. Each question is based on Likert's five-point. The total score is between 36-180 points, the higher the score, the greater the parental pressure.

  T3- preterm infants the first month after discharge

• Caregivers' Stress- T4

  Parenting Stress Index-Third Edition short form (PSI-SF) The PSI Short Form is a direct derivative of the full-length test and consists of a 36-item self-scoring questionnaire/profile. Each question is based on Likert's five-point. The total score is between 36-180 points, the higher the score, the greater the parental pressure.

  T4- preterm infants second month after discharge

• Caregivers' quality of life-T1

  World Health Organization Quality of Life-BREF (WHOQOL-BREF) The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. There are 28 questions in the questionnaire. The content includes four aspects: physical health, psychology, social relations and environment. Each question is based on Likert's five-point. The higher the score, the better the quality of life.

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

• Caregivers' quality of life-T2

  World Health Organization Quality of Life-BREF (WHOQOL-BREF) The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. There are 28 questions in the questionnaire. The content includes four aspects: physical health, psychology, social relations and environment. Each question is based on Likert's five-point. The higher the score, the better the quality of life.

  T2- preterm infants one week before discharge

• Caregivers' quality of life-T3

  World Health Organization Quality of Life-BREF (WHOQOL-BREF) The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. There are 28 questions in the questionnaire. The content includes four aspects: physical health, psychology, social relations and environment. Each question is based on Likert's five-point. The higher the score, the better the quality of life.

  T3- preterm infants the first month after discharge

• Caregivers' quality of life-T4

  World Health Organization Quality of Life-BREF (WHOQOL-BREF) The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. There are 28 questions in the questionnaire. The content includes four aspects: physical health, psychology, social relations and environment. Each question is based on Likert's five-point. The higher the score, the better the quality of life.

  T4- preterm infants second month after discharge

• Caregivers' attachment-T1

  Maternal Attachment Inventory (MAI) The Maternal Attachment Inventory(MAI) has 26 questions on the scale. The questions use a response level of 1 to 4. The 1 point means almost none, 2 points means occasionally, 3 points means often, and 4 points means almost often. The higher the total score, the closer the maternal-infant attachment.

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

• Caregivers' attachment-T2

  Maternal Attachment Inventory (MAI) The Maternal Attachment Inventory(MAI) has 26 questions on the scale. The questions use a response level of 1 to 4. The 1 point means almost none, 2 points means occasionally, 3 points means often, and 4 points means almost often. The higher the total score, the closer the maternal-infant attachment.

  T2- preterm infants one week before discharge

• Caregivers' attachment-T3

  Maternal Attachment Inventory (MAI) The Maternal Attachment Inventory(MAI) has 26 questions on the scale. The questions use a response level of 1 to 4. The 1 point means almost none, 2 points means occasionally, 3 points means often, and 4 points means almost often. The higher the total score, the closer the maternal-infant attachment.

  T3- preterm infants the first month after discharge

• Caregivers' attachment-T4

  Maternal Attachment Inventory (MAI) The Maternal Attachment Inventory(MAI) has 26 questions on the scale. The questions use a response level of 1 to 4. The 1 point means almost none, 2 points means occasionally, 3 points means often, and 4 points means almost often. The higher the total score, the closer the maternal-infant attachment.

  T4- preterm infants second month after discharge

Study Arms (2)

Early Sleep Facilitation Program

EXPERIMENTAL

Perform sleep circadian rhythm training during hospitalization, and provide caregivers with nursing guidance to promote sleep of premature infants before discharge

Behavioral: Early Sleep Facilitation Program; Other: Routine care

routine care and provide general discharge care and nursing guidance

ACTIVE COMPARATOR

Routine care and provide general discharge care and nursing guidance.

Other: Routine care

Interventions

Early Sleep Facilitation Program BEHAVIORAL

It 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 within two months after discharge.

Early Sleep Facilitation Program

Routine care OTHER

Receives routine care and provide general discharge care and nursing guidance.

Early Sleep Facilitation Program; routine care and provide general discharge care and nursing guidance

Eligibility Criteria

• Age: 28 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Defense Medical Center, Taiwan: lead

Study Sites (1)

National defense medical center

Taipei, Taiwan

Location

Study Officials

• Hsiang-Yun Lan, Asst. Prof.

  National Defense Medical Center, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 18, 2021
• Study Start: December 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: November 30, 2023
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)