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Impact and Cost-effectiveness of the Family Integrated Care Model on the Outcomes of Stable Preterm Newborns in Intensive Care Units (NICUs) in China: A Multi-Center Cluster Randomized Controlled Trial

Impact and Cost-effectiveness of the Family Integrated Care Model on the Outcomes of Stable Preterm Newborns in Intensive Care Units (NICUs) in China: A Multi-Center Cluster Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14004736
Enrollment
Unknown
Registered
2014-05-31
Start date
2014-06-02
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Newborn Infants

Interventions

FICare group:Parents will spend at least 6 hours per day in the NICU providing the majority of non-medical care for their infant under the supervision of medical professionals.
Control group:All the care of the newborns in hospital are completed by medical professionals only.
FICare group:Parents will attend regular education sessions to learn the skills necessary to provide care for their infants
FICare group:Nurses will work with parents to support and educate them
FICare group:A training program will be provided for nurses so that they are provided with the tools to support program implementation and act as coaches for parents
FICare group:Each NICU will provide physical supports, such as comfortable chairs at the infant’s bedside and a rest area for parents, and develop policies that support parents’ ability to spend at le

Sponsors

The Third Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: (1) Were born at a gestational age of more than 28 weeks but less than 35 weeks; (2) Have been receiving enteral feeds for more than 24 hours; and (3) Have vital signs that have been stable for more than 24 hours.

Exclusion criteria

Exclusion criteria: (1) Infant requires either invasive or non-invasive ventilation support; (2) Infant requires surgical intervention(s); (3) Infant is receiving palliative care; (4) Parents have severe social issues or there is a language barrier; (5) Infant is likely to be discharged within 1 week; (6) Care-provider is not willing to commit to staying in the hospital for more than 6 hours/day; (7) Parents refuse to give consent; and/or (8) Infant weighs less than 400 g at birth.

Design outcomes

Primary

MeasureTime frame
Duration of hospital stay from admission to discharge home;

Secondary

MeasureTime frame
Total medical expenses;Infection incidence per 1000 hospitalization days;Rate of breast feeding;Parental confidence and stress;Weight gain and growth speed of infants;Time to full feeds;Extra expenses of medical staff;Re-admission rate within 30 days after discharge;

Countries

China

Contacts

Public ContactMingyan Hei

The Third Xiangya Hospital of Central South University

heiming_yan@aliyun.com+86 13707313550

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 2, 2026