Very Premature BabyNCT03668912
Guided Participation Discharge Program for Very Preterm Infants
A study testing Guided participation discharge programme in people with Very Premature Baby, run by Chinese University of Hong Kong.
Trial summary
This study aimed at investigating the feasibility of a new guided participation (GP) discharge program for parents of very preterm infants. A randomized controlled trial was conducted in a neonatal intensive care unit. The intervention included three structured GP sessions and one follow-up phone call. Read more about this study
- Who is it for?
- Ages Up to 32 weeks
- Conditions the study is for
- Very Premature Baby
- What is being tested?
- Guided participation discharge programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2016to 31 Dec 2016
- 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 Up to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- A gestational age of ≤32 weeks at birth
- Must be the infant's primary caregiver
- Diagnosed with a mental illness
Who cannot join
- Have congenital malformation(s)
- Need to undergo a major surgery
- For Parents:
About this study
Official title: Feasibility of a Guided Participation Discharge Program for Very Preterm Infants
This study aimed at investigating the feasibility of a new guided participation (GP) discharge program for parents of very preterm infants. A randomized controlled trial was conducted in a neonatal intensive care unit. The intervention included three structured GP sessions and one follow-up phone call. The control group received usual care. Outcomes measured included parents' efficacy and satisfaction with parenting, and perceived stress. Data collection was conducted at baseline, on day of discharge, after the follow-up phone call, and 1 month after discharge. The outcomes were analyzed on the basis of intention-to-treat principles.
- Conditions
- Very Premature Baby
- Being tested
- Guided participation discharge programme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided participation discharge programmeBehavioural
A nurse-led GP discharge intervention (3 structured 30- to 60-minute GP sessions and 1 follow-up phone call)
| Study group | Role | What they receive |
|---|---|---|
| Guided participation group | Experimental | Not described Receives: Behavioral: Guided participation discharge programme |
| Usual care group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parents' change in score of Parenting Sense of Competence Scale from baseline to up to 8 weeks
The Chinese version of the Parenting Sense of Competence Scale is a self-reported instrument which includes 17 items in two subscales (efficacy and satisfaction). Each item is rated on a 6- point Likert scale ('Strongly disagree' = 1; 'Strongly agree' = 6). Nine items (items 2, 3, 4, 5, 8, 9, 12, 14 and 16) were reverse-coded. The total scores ranged from 17 to 102. A higher score indicates a higher sense of competence and satisfaction with parenting by parents.
Measured: Baseline, and at 3-, 4-, and 8-weeks after baseline
Secondary outcomes (1)
Parents' change in score of Perceived Stress Scale from baseline to up to 8 weeks
The Chinese version of the Perceived Stress Scale consists of 10 items. Each item is rated on a 5-point Likert scale ('never' = 0; 'very often' = 4). The total score is yielded by summing the scores of all items. The total score ranges from 0 to 40. The higher the score, the higher is the parents' perceived stress in parenting.
Measured: Baseline, and at 3-, 4-, and 8-weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start1 Mar 2016
- Primary completion30 Nov 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Very Premature BabyStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lee Suk Yin, Chinese University of Hong Kong
- Investigators
- lsy307@ha.org.hk Lee, Principal investigator, Department of Pediatrics, Prince of Wales Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03668912
- Sponsor's protocol ID
- 001
- Status last verified
- Sep 2018
- First submitted
- 11 Sep 2018
- Last updated
- 14 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee SY, Chau JPC, Choi KC, Lo SHS. Feasibility of a guided participation discharge program for very preterm infants in a neonatal intensive care unit: a randomized controlled trial. BMC Pediatr. 2019 Nov 4;19(1):402. doi: 10.1186/s12887-019-1794-y.
PubMed 31684903
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Guided Participation Discharge Program for Very Preterm Infants
- ClinicalTrials.gov ID
- NCT03668912
- Acronym / sponsor ID
- 001
- Conditions
- Very Premature Baby
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 13 Sep 2018 (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.
This study aimed at investigating the feasibility of a new guided participation (GP) discharge program for parents of very preterm infants. A randomized controlled trial was conducted in a neonatal intensive care unit. The intervention included three structured GP sessions and one follow-up phone call. The control group received usual care. Outcomes measured included parents' efficacy and satisfaction with parenting, and perceived stress. Data collection was conducted at baseline, on day of discharge, after the follow-up phone call, and 1 month after discharge. The outcomes were analyzed on the basis of intention-to-treat principles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guided participation group | Experimental | Behavioral: Guided participation discharge programme |
| Usual care group | No intervention | – |
Who may qualify
- Ages
- Up to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- A gestational age of ≤32 weeks at birth
- Must be the infant's primary caregiver
- Diagnosed with a mental illness
Key exclusion criteria (3 listed)
- Have congenital malformation(s)
- Need to undergo a major surgery
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 |
|---|---|---|
| Guided participation discharge programmeA nurse-led GP discharge intervention (3 structured 30- to 60-minute GP sessions and 1 follow-up phone call) | Behavioural | Guided participation group |
Primary outcome
Parents' change in score of Parenting Sense of Competence Scale from baseline to up to 8 weeks
Time frame: Baseline, and at 3-, 4-, and 8-weeks after baseline
The Chinese version of the Parenting Sense of Competence Scale is a self-reported instrument which includes 17 items in two subscales (efficacy and satisfaction). Each item is rated on a 6- point Likert scale ('Strongly disagree' = 1; 'Strongly agree' = 6). Nine items (items 2, 3, 4, 5, 8, 9, 12, 14 and 16) were reverse-coded. The total scores ranged from 17 to 102. A higher score indicates a higher sense of competence and satisfaction with parenting by parents.
1 secondary outcome
Parents' change in score of Perceived Stress Scale from baseline to up to 8 weeks
Time frame: Baseline, and at 3-, 4-, and 8-weeks after baseline
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 Sep 2018.
- Derived from this study: PubMed 31684903Lee SY, Chau JPC, Choi KC, Lo SHS. Feasibility of a guided participation discharge program for very preterm infants in a neonatal intensive care unit: a randomized controlled trial. BMC Pediatr. 2019 Nov 4;19(1):402. doi: 10.1186/s12887-019-1794-y.
- Individual participant dataSharing planned: No
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.
lsy307@ha.org.hk Lee principal investigator
Department of Pediatrics, Prince of Wales Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Guided participation discharge programme in people with Very Premature Baby, run by Chinese University of Hong Kong.
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 3 inclusion and 3 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 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Parents' change in score of Parenting Sense of Competence Scale from baseline to up to 8 weeks (time frame: Baseline, and at 3-, 4-, and 8-weeks after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03668912, which also lists 1 linked publication.
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 Sep 2018; AzTrials last refreshed its copy on 29 Oct 2026.