Clinical trial NCT06613386: Effects of an Information-Based Discharge Service on Preterm Infants, Parents, and Hospitals
Official title: The Effects of an Information-Based Discharge Preparation Service on the Outcomes of Preterm Infant, Parent, and Hospital: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Patient Discharge
Infant, Premature
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Chinese Medical Association
First posted: 2024-09-26
Enrollment: 86
Sex: ALL
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study employs a prospective, double-arm, randomized controlled trial (RCT) design, conducted in the Neonatal Intensive Care Units (NICU) of a tertiary first-class hospital in Jiangsu Province, China.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Background:The Information-Based Discharge Preparation Service (IBDPS) supports parents of preterm infants during the transition from hospital to home, but its effectiveness has not been widely studied.

Objective:To evaluate the impact of IBDPS on parental readiness, caregiving skills, stress, satisfaction, infant development, readmission rates, length of stay, and hospital costs.

Design: A randomized controlled trial (RCT) in a NICU in Jiangsu Province, China.

Participants: Preterm infants and their parents.

Methods:Participants are randomly assigned to receive either IBDPS plus usual care (intervention group) or usual care alone (control group). Data on parental and infant outcomes are collected at various stages from admission to one month post-discharge, along with hospital metrics like length of stay and readmission rates.

Detailed description: Participants are randomly allocated to the intervention and control groups. The intervention group receives the IBDPS in addition to the usual care, while the control group receives only the usual discharge education. The IBDPS, grounded in the theories of empowerment and "Timing It Right (TIR)," leverages an information-based platform to provide continuous, multidimensional, and customized support to parents from their infants' admission to one month post-discharge, ensuring seamless integration of discharge preparation both online and offline, and within and outside the hospital. Baseline data are collected at allocation (T1). Parental outcomes, including readiness for hospital discharge and stress, are assessed at T1, upon NICU entry (T2), and prior to discharge (T3), while caregiving skills are measured at T1, T2, T3, and one month post-discharge (T4). Parental satisfaction is measured at T3. Infant outcomes, such as weight, length, head circumference, breastfeeding rate, and feeding intolerance rate, are recorded at T1, T2, T3, and T4, with Neonatal Behavior Neurologic Assessment (NBNA) scores evaluated at T4. Hospital outcomes include length of stay and hospitalization costs, assessed at T3, and unplanned readmissions, recorded at T4.

Eligibility criteria: Inclusion Criteria for Infants:

* Infants with a gestational age of less than 37 weeks at birth.
* Written informed consent obtained from legal guardians.
* Neonates delivered at the study hospital or transferred within the first 24 hours of life.

Exclusion Criteria for Infants:

* Presence of major life-threatening congenital anomalies.
* Critical illness or conditions requiring immediate intensive intervention.
* Significant developmental abnormalities, including but not limited to severe congenital malformations, metabolic disorders, or central nervous system anomalies.

Removal Criteria for Infants:

* Infants who experience abnormal discharge due to treatment abandonment, death, or transfer to another facility.

Inclusion Criteria for Parents:

* Parents of infants born at less than 37 weeks of gestational age.
* Written informed consent provided by the parents.
* Ability to dedicate at least 4 hours per day to infant care.
* Adequate reading comprehension and proficiency in using electronic devices.
* If multiple caregivers are involved, the primary caregiver with the most hours of caregiving will be selected.

Exclusion Criteria for Parents:

* Health, familial, social, or language barriers that impair effective integration into the healthcare team.

Removal Criteria for Parents:

* Voluntary withdrawal from the study.
* Non-compliance with study protocols.

Primary outcomes:
measure: Readiness for Hospital Discharge Scale
timeFrame: From enrollment until the preterm infants discharge, with assessments at enrollment, parent entry into the NICU, and discharge,assessed up to 90 days.
Secondary outcomes:
measure: Self-Assessment Questionnaire for Caregiving Ability of Parents of Preterm Infants
timeFrame: From enrollment until the preterm infants discharge, with assessments at enrollment, parent entry into the NICU, discharge,and one month after discharge,assessed up to 120 days.
Other outcomes:
measure: Parental Stressor Scale: NICU
timeFrame: From the time of enrollment until the discharge of the preterm infant, with allocations made at enrollment, upon the parent entry into the NICU, and at discharge, assessed over a period of up to 90 days
measure: Parent Satisfaction Scale for Continuity of Care for Preterm Infants
timeFrame: Through the study completion, one month post-discharge,assessed up to 120 days.
measure: Physical Development Outcomes
timeFrame: From enrollment until the preterm infants discharge, with assessments at enrollment, parent entry into the NICU, discharge,and one month after discharge,assessed up to 120 days.
measure: Neurobehavioral Development Outcomes
timeFrame: Through the study completion, one month post-discharge,assessed up to 120 days.
measure: Breastfeeding rate
timeFrame: From enrollment until the preterm infants discharge, with assessments at enrollment, parent entry into the NICU, discharge,and one month after discharge,assessed up to 120 days.
measure: Incidence of feeding intolerance
timeFrame: From enrollment until the preterm infants discharge, with assessments at enrollment, parent entry into the NICU, discharge,and one month after discharge,assessed up to 120 days.
measure: Length of Stay (LOS)
timeFrame: Until the discharge of the preterm infant, at the time of discharge,assessed up to 90 days.
measure: Hospitalization Costs
timeFrame: Until the discharge of the preterm infant,at the time of discharge,assessed up to 90 days.
measure: Readmission Rate Within One Month Post-Discharge
timeFrame: Through the study completion,one month post-discharge,assessed up to 120 days.
Locations:
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Caoyuan Wang, Master
role: STUDY_DIRECTOR
References:
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