About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Infants who experience abnormal discharge due to treatment abandonment, death, or transfer to another facility.
Trial design
Parallel
Treatments tested in this trial
The information-based discharge preparation service (IBDPS)
Other interventionThe main modules of the IBDPS platform include: * Establishing information records for infants and parents. * Collaboratively identifying existing or potential caregiving challenges. * Assessing parents' emotional and psychological states, providing support and intervention. * Collaboratively establishing caregiving objectives with parents. * Collaboratively formulating and executing caregiving plans. * Assessing parental support resources, offering analysis, assistance, and necessary referrals. * Conducting outcome assessments.
Treatment groups
Trial outcomes
Primary outcomes
Readiness for Hospital Discharge Scale
The Readiness for Hospital Discharge Scale (RHDS) - Parent Form was originally developed by Weiss et al. for assessing the readiness of parents for the discharge of their hospitalized children (0 to 18 years old). The Chinese version of the Readiness for Hospital Discharge Scale (C-RHDS) - Parent Form, adapted by Chen et al. with authorization from the original authors, is utilized to evaluate the readiness of parents for the discharge of preterm infants. This 22-item scale includes four dimensions: Knowledge (9 items), Physical-emotional Status (7 items), Pain Status (2 items), and Expected Support (4 items). Each item is scored on a scale from 0 to 10 (0 = worst; 10 = best), with total scores ranging from 0 to 220. Higher scores reflect better readiness for discharge. The overall Cronbach α coefficient for this scale is 0.91.
Secondary outcomes
Self-Assessment Questionnaire for Caregiving Ability of Parents of Preterm Infants
The Chinese version of the Self-Assessment Questionnaire for Caregiving Ability of Parents of Preterm Infants, developed by Meng et al., is used to evaluate the caregiving ability of parents with preterm infants. This questionnaire consists of 18 items rated on a Likert scale from 1 to 5 (1 = not at all familiar; 5 = very familiar). It is divided into three dimensions: Knowledge of Preterm Infant Care (7 items), Caregiving Skills (7 items), and Caregiving Ability (4 items). The total score ranges from 18 to 90, with higher scores indicating better caregiving ability. The Cronbach α coefficient for the overall scale is 0.956.
Other outcomes
Parental Stressor Scale: NICU
The Parental Stressor Scale: NICU (PSS: NICU) was originally developed by Miles and Funk et al. to measure parental stress during NICU hospitalization of their infants. The Chinese version of the Parental Stressor Scale: NICU (C-PSS: NICU), adapted by Li et al. with authorization from the original authors, uses a 5-point Likert scale (1 = no stress or anxiety; 5 = extreme stress or anxiety). This scale, consisting of 25 items, is divided into three dimensions: Infant Behavior and Appearance (13 items), Parental Role Alteration(7 items), and Sights and Sounds(5 items).The total score ranges from 25 to 125, with higher scores reflecting greater levels of parental stress and anxiety. The scale demonstrates strong internal consistency, with a Cronbach α coefficient of 0.856.
Parent Satisfaction Scale for Continuity of Care for Preterm Infants
The Parent Satisfaction Scale for Continuity of Care for Preterm Infants, developed by Qian et al., can be used to assess parental satisfaction with discharge preparation services for preterm infants. This 21-item scale employs a 5-point Likert scale, where responses range from 0 (very dissatisfied) to 4 (very satisfied). The scale is structured into four dimensions: Nurse Appearance and Attitude(3 items),Continuity of Care Competence(11 items), Humanistic Quality(4 items), and Overall Evaluation of Continuity of Care Services(3 items).The scoring method is based on a percentage system, calculated as follows: (sum of scores for valid responses ÷ number of valid responses ÷ 4) × 100. Higher scores indicate greater satisfaction. The Cronbach α coefficient for the overall scale is 0.807.
Physical Development Outcomes
Indicators such as weight, length, and head circumference are measured using standardized neonatal techniques with calibrated scales and measuring tapes.
Neurobehavioral Development Outcomes
Assessed using the Neonatal Behavior Neurologic Assessment (NBNA), a tool widely used in China to evaluate neurobehavioral development. NBNAis divided into five components: behavioral capability (6 items), passive muscle tone (4 items), active muscle tone (4 items), primitive reflexes (3 items), and general assessment (3 items). Each item is scored on a 3-point Likert scale ranging from 0 to 2, with a total possible score of 40. A score of ≤35 indicates abnormality.
Locations
Sponsors and contacts
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The First Affiliated Hospital with Nanjing Medical University
Lead sponsor
Chinese Medical Association
Collaborator
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