Skip to main content
OpenTrials
Completed

NCT Number: NCT07137741

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Premature Infants Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

28 week–36 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yongkang maternal and Child Health Hospital

Guli, Zhejiang, 321300, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FICare nursing method guided by Swanson's caring theory

Behavioral

encompasses the following five dimensions: Understanding: A neonatologist provided a comprehensive explanation regarding the developmental progress of premature infants, potential complications, and essential aspects of nursing care to ensure the family gained a thorough understanding of the care requirements for premature infants.

Accompaniment: Two nursing guides provided essential support to parents of newborns in the NICU, helping to alleviate the anxiety and sense of helplessness among family members and fostering a relationship of trust between the medical staff and the families.

Help: A neonatal nurse played a guiding role in facilitating parental involvement in the daily care of premature infants, which encompassed feeding guidance, introduction of complementary foods, skin care, and related aspects.

Empowerment: A psychological counselor was assigned to provide psychological counseling and guidance to new parents, offering appropriate emotional support and assisting them in ac

Primary outcomes

  1. head circumference

    Time frame: 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.

  2. body weight

    Time frame: 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.

  3. body length

    Time frame: 6 months

    To measure a preterm infant's length: extend body, align head/heel, use a length board, read to 0.1cm, repeat, record.

  4. STAI scores

    Time frame: 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.

  5. PSOC scores

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yongkang Maternal and Child Health Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Aug 22, 2025
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.