Family Centered CareNCT07122830
Family Integrated Care: A Feasibility Study in a Level II Special Care Nursery
A study testing Family Education and Parental Involvement in people with Family Centered Care and Neonatal, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Family Centered Care, Neonatal
- What is being tested?
- Family Education and Parental Involvement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSingapore
- Study dates
- 15 May 2024to 24 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: From Intention to Implementation: Evaluating the Feasibility and Acceptability of Family Integrated Care in 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?
- Conditions
- Family Centered Care, Neonatal
- Being tested
- Family Education and Parental Involvement
- Keywords
- Feasibility, Family Integrated Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Education and Parental InvolvementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| FIC Group | Active comparator | Not described Receives: Other: Family Education and Parental Involvement |
| Control Group | No intervention | The usual standard of care will be provided for this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
This study will examine the length of time taken to complete participant recruitment, and recruitment rates.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 1 year
Secondary outcomes (9)
Parental Self-Efficacy
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.
Measured: Through grant period, up to 6 months
Frequency of Parental Visits
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.
Measured: Through grant period, up to 6 months
Frequency of Kangaroo Care
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.
Measured: Through grant period, up to 6 months
Duration of Kangaroo Care
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.
Measured: Through grant period, up to 6 months
Frequency of Breastfeeding
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.
Measured: Through grant period, up to 6 months
Duration of Breastfeeding
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.
Measured: Through grant period, up to 6 months
Length of Stay
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.
Measured: Through grant period, up to 6 months]
Infants Weight Gain
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).
Measured: Through grant period, up to 6 months
Nasogastric Tube Retention Time
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.
Measured: Through grant period, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start15 May 2024
- Primary completion24 Apr 2025
- Study completion24 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family Centered CareStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Chan Shu Hui, KK Women's and Children's Hospital
- Investigators
- Shu Hui Chan, BSc (Nursing) (Honours), Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122830
- Sponsor's protocol ID
- 2023-2643
- Other IDs
- CRADLE/2023/RES/003
- Status last verified
- Aug 2025
- First submitted
- 20 Jul 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Intention to Implementation: Evaluating the Feasibility and Acceptability of Family Integrated Care in Special Care Nursery
- ClinicalTrials.gov ID
- NCT07122830
- Acronym / sponsor ID
- 2023-2643
- Conditions
- Family Centered Care, Neonatal
- Keywords
- Feasibility, Family Integrated Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 15 May 2024 (actual)
- Primary completion
- 24 Apr 2025 (actual)
- Study completion
- 24 Apr 2025 (actual)
- First posted
- 14 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Education and Parental InvolvementParents 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. | Other | FIC Group |
Primary outcome
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.
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.
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.
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.
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.
9 secondary outcomes
Parental Self-Efficacy
Time frame: Through grant period, up to 6 months
Frequency of Parental Visits
Time frame: Through grant period, up to 6 months
Frequency of Kangaroo Care
Time frame: Through grant period, up to 6 months
Duration of Kangaroo Care
Time frame: Through grant period, up to 6 months
Frequency of Breastfeeding
Time frame: Through grant period, up to 6 months
Duration of Breastfeeding
Time frame: Through grant period, up to 6 months
Length of Stay
Time frame: Through grant period, up to 6 months]
Infants Weight Gain
Time frame: Through grant period, up to 6 months
Nasogastric Tube Retention Time
Time frame: Through grant period, up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shu Hui Chan, BSc (Nursing) (Honours) principal investigator
KK Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Education and Parental Involvement in people with Family Centered Care and Neonatal, run by KK Women's and Children's Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: Through grant period, up to 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.