Guided Participation Discharge Program for Very Preterm Infants

NCT ID: NCT03668912

Last Updated: 2018-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-01

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Very Premature Baby

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Guided participation group

Group Type EXPERIMENTAL

Guided participation discharge programme

Intervention Type BEHAVIORAL

A nurse-led GP discharge intervention (3 structured 30- to 60-minute GP sessions and 1 follow-up phone call)

Usual care group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Guided participation discharge programme

A nurse-led GP discharge intervention (3 structured 30- to 60-minute GP sessions and 1 follow-up phone call)

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

\- A gestational age of ≤32 weeks at birth


\- Must be the infant's primary caregiver


\- Diagnosed with a mental illness

Exclusion Criteria

* Have congenital malformation(s)
* Need to undergo a major surgery

For Parents:
Maximum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Lee Suk Yin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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[email protected] Lee

Role: PRINCIPAL_INVESTIGATOR

Department of Pediatrics, Prince of Wales Hospital

References

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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.

Reference Type DERIVED
PMID: 31684903 (View on PubMed)

Other Identifiers

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001

Identifier Type: -

Identifier Source: org_study_id

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