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

From Intention to Implementation: Evaluating the Feasibility and Acceptability of Family Integrated Care in Special Care Nursery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07122830
Enrollment
13
Registered
2025-08-14
Start date
2024-05-15
Completion date
2025-04-24
Last updated
2025-08-14

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

Conditions

Family Centered Care, Neonatal

Keywords

Feasibility, Family Integrated Care

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?

Interventions

OTHERFamily Education and Parental Involvement

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.

Sponsors

KK Women's and Children's Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Recruitment RateThrough grant period, up to 6 monthsThis study will examine the length of time taken to complete participant recruitment, and recruitment rates.
Retention RatesUp to 6 monthsThis will be evaluated by examining the participants drop-out rates throughout the study. This will be used to assess the fidelity of the program.
Completion of FIC programThrough grant period, up to 6 monthsThis 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.
Parent Experience of FIC ProgramThrough grant period, up to 6 monthsParents 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.
Nurses' Experience of the FIC ProgramUp to 1 yearNurses 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.

Secondary

MeasureTime frameDescription
Duration of BreastfeedingThrough grant period, up to 6 monthsThis study aims to assess whether mothers in the FIC group engage in longer breastfeeding sessions, measured by the number of minutes, compared to those in the control group.
Length of StayThrough grant period, up to 6 months]This study aims to evaluate whether infants in the FIC group have a shorter length of stay, measured in the number of days, compared to the control group.
Parental Self-EfficacyThrough grant period, up to 6 monthsParents will complete the Perceived Maternal Parenting Self-Efficacy (PMPS-E) Questionnaire pre-test and post-test to evaluate for improvements in their self-efficacy after going through the intervention. The PMPS-E Questionnaire is a 20-item questionnaire that uses a 4-point Likert scale ranging from 'Strongly Disagree' (Score = 1), 'Disagree' (Score = 2), 'Agree' (Score = 3), and 'Strongly Agree' (Score = 4). Participants can score between 20 to 80, where a higher score reflects higher self-efficacy.
Nasogastric Tube Retention TimeThrough grant period, up to 6 monthsThis study aims to assess whether infants in the FIC group are able to achieve full oral feeding earlier than infants in the control group. This will be evaluated using the duration of their nasogastric tube retention time, measured in the number of days.
Infants Weight GainThrough grant period, up to 6 monthsThis study aims to assess whether infants in the FIC Group have higher weight gain compared to infants in the control group. The infants' birth weight and weight at discharge, measured in grams, will be collected and calculated \[discharge weight (g) - birth weight (g)\] to derive the infants' weight gain (g).
Frequency of Parental VisitsThrough grant period, up to 6 monthsThis study aims to evaluate whether parents in the FIC group have a higher frequency of visits, measured in number of days, compared to those in the control group.
Frequency of Kangaroo CareThrough grant period, up to 6 monthsThis study aims to evaluate whether parents in the FIC group have practice kangaroo care more often, measured in number of times done, compared to those in the control group.
Duration of Kangaroo CareThrough grant period, up to 6 monthsThis study aims to evaluate whether parents in the FIC group carry our kangaroo care for longer periods of time, measured in number of minutes, compared to those in the control group.
Frequency of BreastfeedingThrough grant period, up to 6 monthsThis study aims to assess whether mothers in the FIC group engage in more breastfeeding, as measured by the number of feeds, compared to those in the control group.

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026