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

3 de mayo de 2026 actualizado por: Hsiang-Yun Lan, National Defense Medical Center, Taiwan

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

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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

86

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Taipei, Taiwán
        • National Defense Medical Center

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

6 meses a 8 meses (Niño)

Acepta Voluntarios Saludables

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Investigación de servicios de salud
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Early Sleep Facilitation Program
Perform sleep circadian rhythm training during hospitalization, and provide caregivers with nursing guidance to promote sleep of premature infants before discharge
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.
Receives routine care and provide general discharge care and nursing guidance.
Comparador activo: routine care and provide general discharge care and nursing guidance
Routine care and provide general discharge care and nursing guidance.
Receives routine care and provide general discharge care and nursing guidance.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Preterm Infants' Sleep- Actigraphy -T1
Periodo de tiempo: T1-baseline collect preterm infants after 32 weeks of gestation before intervention
Accessed by Actigraphy
T1-baseline collect preterm infants after 32 weeks of gestation before intervention
Preterm Infants' Sleep- Actigraphy -T2
Periodo de tiempo: T2- preterm infants one week before discharge
Accessed by Actigraphy
T2- preterm infants one week before discharge
Preterm Infants' Sleep- Actigraphy -T3
Periodo de tiempo: T3- preterm infants the first month after discharge
Accessed by Actigraphy
T3- preterm infants the first month after discharge
Preterm Infants' Sleep- Actigraphy -T4
Periodo de tiempo: T4- preterm infants second month after discharge
Accessed by Actigraphy
T4- preterm infants second month after discharge
Preterm Infants' Sleep- sleep log -T1
Periodo de tiempo: T1-baseline collect preterm infants after 32 weeks of gestation before intervention
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
Periodo de tiempo: T2- preterm infants one week before discharge
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
Periodo de tiempo: T3- preterm infants the first month after discharge
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
Periodo de tiempo: T4- preterm infants second month after discharge
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
Periodo de tiempo: T1-baseline collect preterm infants after 32 weeks of gestation before intervention

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
Periodo de tiempo: T2- preterm infants one week before discharge

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
Periodo de tiempo: T3- preterm infants the first month after discharge

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
Periodo de tiempo: T4- preterm infants second month after discharge

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
Periodo de tiempo: T1-baseline collect preterm infants after 32 weeks of gestation before intervention

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
Periodo de tiempo: T2- preterm infants one week before discharge

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
Periodo de tiempo: T3- preterm infants the first month after discharge

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
Periodo de tiempo: T4- preterm infants second month after discharge

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
Periodo de tiempo: T1-baseline collect preterm infants after 32 weeks of gestation before intervention
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
Periodo de tiempo: T2- preterm infants one week before discharge
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
Periodo de tiempo: T3- preterm infants the first month after discharge
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
Periodo de tiempo: T4- preterm infants second month after discharge
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
Periodo de tiempo: T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention
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
Periodo de tiempo: T2- preterm infants one week before discharge
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
Periodo de tiempo: T3- preterm infants the first month after discharge
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
Periodo de tiempo: T4- preterm infants second month after discharge
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
Periodo de tiempo: T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention
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
Periodo de tiempo: T2- preterm infants one week before discharge
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
Periodo de tiempo: T3- preterm infants the first month after discharge
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
Periodo de tiempo: T4- preterm infants second month after discharge
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
Periodo de tiempo: T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention
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
Periodo de tiempo: T2- preterm infants one week before discharge
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
Periodo de tiempo: T3- preterm infants the first month after discharge
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
Periodo de tiempo: T4- preterm infants second month after discharge
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
Periodo de tiempo: T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention
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
Periodo de tiempo: T2- preterm infants one week before discharge
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
Periodo de tiempo: T3- preterm infants the first month after discharge
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
Periodo de tiempo: T4- preterm infants second month after discharge
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
Periodo de tiempo: T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention
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
Periodo de tiempo: T2- preterm infants one week before discharge
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
Periodo de tiempo: T3- preterm infants the first month after discharge
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
Periodo de tiempo: T4- preterm infants second month after discharge
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
Periodo de tiempo: T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention

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
Periodo de tiempo: T2- preterm infants one week before discharge

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
Periodo de tiempo: T3- preterm infants the first month after discharge

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
Periodo de tiempo: T4- preterm infants second month after discharge

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Hsiang-Yun Lan, Asst. Prof., National Defense Medical Center, Taiwan

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de diciembre de 2020

Finalización primaria (Actual)

1 de diciembre de 2022

Finalización del estudio (Actual)

30 de noviembre de 2023

Fechas de registro del estudio

Enviado por primera vez

28 de mayo de 2021

Primero enviado que cumplió con los criterios de control de calidad

12 de junio de 2021

Publicado por primera vez (Actual)

18 de junio de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

3 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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