Clinical trial NCT06635473: Effect of Intelligent Intervention Strategies on Self-efficacy and Hospital Readiness of Parents of Preterm Infants
Official title: Effect of Intelligent Intervention Strategies on Self-efficacy and Hospital Readiness of Parents of Preterm Infants: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Premature Delivery
Lead sponsor: Shantou University Medical College
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 1. Construct intelligent management intervention plan for parents of preterm infants from hospital to family based on the medical and health system suitable for China's national conditions.
2. Clinical randomized controlled trials were conducted to verify and evaluate the feasibility and application effect of the intervention program.

Detailed description: Based on the previous literature analysis, this study builds an intelligent intervention scheme based on evidence-based methods and theories. Finally, we selected the parents of preterm infants in the neonatology department of a third class hospital in Shantou to carry out a similar experiment to verify the scheme. With data collected at five critical time points and different interventions provided according to baseline data, the study will reveal significant differences in personalized interventions, self-efficacy at different time points, and hospital discharge readiness among parents of preterm infants in the context of intelligent intervention, showing the relationship between self-efficacy and hospital discharge readiness. This study will fill in the single, traditional model of education and provide new perspectives and methods for future research and clinical practice.

Eligibility criteria: Inclusion Criteria:

1. Inclusion criteria for premature infants ① gestational age \&lt; 37 weeks；② Premature infants admitted to NICU；③ The duration of hospitalization is more than 5 days.
2. Inclusion and exclusion criteria of primary caregivers of preterm infants ① Preterm infants admitted to neonatology and family caregivers of preterm infants with gestational age \&lt; 37 weeks. ② Family members who volunteer to undertake primary care tasks. ③ No mental disorders and can carry out normal language communication； ④ ≥18 years old, proficient in WeChat use；⑤ Informed consent has been signed.

Exclusion Criteria:

1. Exclusion criteria for preterm infants ① intrauterine developmental retardation of preterm infants. ② Preterm infants with a history of major surgery. ③ Unplanned discharge, transfer, transfer or death of premature infants.
2. Exclusion criteria for primary caregivers of preterm infants ① There are recent major mental trauma injuries caused by non-hospitalization factors. ② the caregiver suffers from serious diseases of the heart, brain, lung, kidney and other organs. 3. Shedding criteria: Caregivers who voluntarily asked to withdraw for various reasons during the study.

Primary outcomes:
measure: Parental readiness for discharge
timeFrame: Upon admission and 24 hours before discharge
measure: Parents' self-efficacy
timeFrame: The day of admission, 24 hours before discharge, and 1 month after discharge
Secondary outcomes:
measure: Anxiety
timeFrame: The day of admission, 24 hours before discharge, and 1 month after discharge
measure: Growth and development indicators of premature infants
timeFrame: 1 week, 1 month, 3 months after discharge
measure: Readmission rate of preterm infants
timeFrame: One month after discharge
measure: Parental care ability
timeFrame: The day of admission, 24 hours before discharge, and 1 month after discharge
measure: Breastfeeding situation
timeFrame: 1 week, 1 month, 3 months after discharge
Other outcomes:
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