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Completed

NCT Number: NCT07122830

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

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?

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Key information

Conditions

Family Centered Care Neonatal

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KK Women's and Children's Hospital

Singapore, 229899

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

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.

Primary outcomes

  1. Recruitment Rate

    Time frame: Through grant period, up to 6 months

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

  2. Retention Rates

    Time frame: Up to 6 months

    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.

  3. Completion of FIC program

    Time frame: Through grant period, up to 6 months

    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.

  4. Parent Experience of FIC Program

    Time frame: Through grant period, up to 6 months

    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.

  5. Nurses' Experience of the FIC Program

    Time frame: Up to 1 year

    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.

Secondary outcomes

  1. Parental Self-Efficacy

    Time frame: Through grant period, up to 6 months

    Parents 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.

  2. Frequency of Parental Visits

    Time frame: Through grant period, up to 6 months

    This 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.

  3. Frequency of Kangaroo Care

    Time frame: Through grant period, up to 6 months

    This 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.

  4. Duration of Kangaroo Care

    Time frame: Through grant period, up to 6 months

    This 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.

  5. Frequency of Breastfeeding

    Time frame: Through grant period, up to 6 months

    This 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.

  6. Duration of Breastfeeding

    Time frame: Through grant period, up to 6 months

    This 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.

  7. Length of Stay

    Time frame: Through 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.

  8. Infants Weight Gain

    Time frame: Through grant period, up to 6 months

    This 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).

  9. Nasogastric Tube Retention Time

    Time frame: Through grant period, up to 6 months

    This 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.

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 14, 2025
Registry last updated
Aug 14, 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.

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