The Effect of Family-Integrated Care Based on Swanson's Theory of Caring on Premature Infants

Not Applicable

Completed

• Conditions: Premature Infants

• Registration Number: NCT07137741
• Lead Sponsor: Yongkang Maternal and Child Health Hospital

Brief Summary

Previous studies have demonstrated that the implementation of FICare in single-family neonatal units is associated with a reduced risk of late-onset sepsis among preterm infants, a shorter hospital length of stay, a lower risk of rehospitalization, and improved breastfeeding rates.However, the impact of FICare, guided by Swanson's caring theory, on the growth and development of newborns, as well as on parental anxiety and their sense of parenting competence, remains unclear. To address this gap, the investigators conducted a cohort study to investigate these outcomes.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-01
• Primary Completion: 2023-11-25
• Study Completion: 2024-08-30
• Status Verified: 2025-08
• Study First Submitted: 2025-08-07
• Study First Submitted QC: 2025-08-15
• Last Update Submitted: 2025-08-15
• Study First Posted: 2025-08-22
• Last Update Posted: 2025-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• gestational age ranging from 28 to 36 weeks
• stable vital signs for at least 24 hours
• parental accompaniment of preterm infants during hospitalization

Exclusion Criteria

• preterm infants with severe congenital or genetic disorders
• preterm infants with dysfunction of vital organs
• preterm infants requiring mechanical life support
• preterm infants requiring surgical intervention
• preterm infants with a birth weight below 500 grams

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
head circumference	6 months	To measure a preterm infant's head circumference: use a soft tape, wrap snugly over supraorbital ridges and occipital protuberance, read to 0.1cm, repeat twice, record.
body weight	6 months	To measure a preterm infant's weight: place on a calibrated, zeroed electronic scale (nappy only), ensure stillness, read to 0.1g, repeat twice, record with date/time.
body length	6 months	To measure a preterm infant's length: extend body, align head/heel, use a length board, read to 0.1cm, repeat, record.
STAI scores	6 months	STAI (State-Trait Anxiety Inventory) scores assess anxiety levels via two scales: State Anxiety (S-AI) measures temporary anxiety, Trait Anxiety (T-AI) assesses general anxiety proneness.; Each has 20 items, rated 1-4. Scores range 20-80; higher scores indicate greater anxiety. S-AI ≥40 suggests significant state anxiety; T-AI ≥40 may indicate trait anxiety.
PSOC scores	6 months	PSOC (Parenting Sense of Competence Scale) scores assess parental self-efficacy and satisfaction. It has 17 items, rated 1-6, covering efficacy (confidence) and satisfaction (emotional engagement). Scores range 17-102; higher scores mean stronger. parenting competence.

Trial Locations

Locations (1)

Yongkang maternal and Child Health Hospital; 🇨🇳 Yongkang, Zhejiang, China

Yongkang maternal and Child Health Hospital

🇨🇳Yongkang, Zhejiang, China