Family Integrated Care: A Feasibility Study in a Level II Special Care Nursery

NCT07122830 | Completed

• 2 other identifiers: 2023-2643CRADLE/2023/RES/003
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this mixed methods study is to assess the feasibility and acceptability of a parent-led family integrated care program in a Level II neonatal unit. The main questions it aims to answer are:

• Is it feasible to implement a parent-led Family Integrated Care (FIC) program in a Level II neonatal unit?
• How acceptable is the FIC program to parents and nurses?
• Can the FIC program help improve parental self-efficacy and infant outcomes?

Conditions

Family Centered Care; Neonatal

Keywords

Feasibility; Family Integrated Care

Outcome Measures

Primary Outcomes (5)

• Recruitment Rate

  This study will examine the length of time taken to complete participant recruitment, and recruitment rates.

  Through grant period, up to 6 months

• Retention Rates

  This will be evaluated by examining the participants drop-out rates throughout the study. This will be used to assess the fidelity of the program.

  Up to 6 months

• Completion of FIC program

  This will be evaluated by examining the percentage completion of the FIC program teaching sessions by each participant. This will be used to assess the fidelity of the program.

  Through grant period, up to 6 months

• Parent Experience of FIC Program

  Parents will have a semi-structured interviews to have a qualitative evaluation of their experience of the FIC program. This study aims to identify any barriers and/or facilitating factors of the program.

  Through grant period, up to 6 months

• Nurses' Experience of the FIC Program

  Nurses will have a quantitative and qualitative evaluation of the program through a post-implementation survey and focused group discussion respectively. This study aims to identify any barriers and/or facilitators through their experience. The nurses' survey consists of 8-items, scored on a 5-point Likert scale. Nurses can score between 8 - 40, with a higher score reflecting a better experience of the FIC program.

  Up to 1 year

Secondary Outcomes (9)

• Parental Self-Efficacy

  Through grant period, up to 6 months

• Frequency of Parental Visits

  Through grant period, up to 6 months

• Frequency of Kangaroo Care

  Through grant period, up to 6 months

• Duration of Kangaroo Care

  Through grant period, up to 6 months

• Frequency of Breastfeeding

  Through grant period, up to 6 months

Study Arms (2)

FIC Group

ACTIVE COMPARATOR

Other: Family Education and Parental Involvement

Control Group

NO INTERVENTION

The usual standard of care will be provided for this group.

Interventions

Family Education and Parental Involvement OTHER

Parents will be oriented to the programme, tools provided for their own learning (pamphlets, information handouts, audio-visual resources), and a checklist of infant care topics to be completed. The primary caregiver will be asked to commit to spending one to two hours per day to attend education sessions on the topic(s) of their choice. Parents will be encouraged to provide progressively more daily care for their infants as they complete more education sessions. After each education session, parents will check off for each completed topic on their skills checklist.

FIC Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parents of infants admitted to the Level II neonatal unit who anticipate at least 2 weeks of stay
• Parents of infants who can commit to coming daily for one to two hours.

You may not qualify if:

• Infants have severe congenital anomalies
• Infants receiving pallitaive care
• Infants who are critically ill / deemed unlikely to survive
• Infants scheduled for early transfer
• Parents are unable to participate due to health, social, or language issues that would inhibit their communication with the medical and nursing team.

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

Study Officials

• Shu Hui Chan, BSc (Nursing) (Honours)

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 20, 2025
• First Posted: August 14, 2025
• Study Start: May 15, 2024
• Primary Completion: April 24, 2025
• Study Completion: April 24, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: IPD and supporting information will be stored and available for 10 years from 24 April 2025 until 1 April 2035. Thereafter, the stored IPD will be deleted and destroyed in accordance with PDPA guidelines of the hospital.
• Access Criteria: Only the principle investigator will be able to access it via an encrypted access to the excel spreadsheet.

Locations

SG (1)