NCT02581800

Brief Summary

Background: Premature infants and their patents are discharged earlier from hospital and sent home in early in-homecare programs. Research regarding the use of health IT is needed to say, whether the use of videoconference and Smartphone application is a viable option to address the parents need for support in relations to early discharge. Aim: Test and explore early in-homecare (PreHomeCare) with videoconference and mobile application versus hospital consultations. Method: Main study; a randomized controlled intervention study with the hypothesis; parent of premature infants who have access to electronic knowledge and participatory guidance 24-7: increases proportion of exclusive breastfeeding, Improves parent/infant interaction, enhances confidence and increases knowledge. Sub study 1; a field study. Sub study 2; an interview study. Perspectives: It is expected that this project will be an argument in development of care for premature infants and telemedicine use in the future

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 21, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

October 12, 2018

Status Verified

October 1, 2018

Enrollment Period

2.9 years

First QC Date

October 19, 2015

Last Update Submit

October 10, 2018

Conditions

Infants, PrematureBreastfeedingTelecommunicationPatient DischargeNursing

Outcome Measures

Primary Outcomes (1)

  • Proportion of breastfeeding

    one month after discharge

Secondary Outcomes (3)

  • Parents feeling of confidence

    one month after discharge

  • Parent/child interaction

    one month after discharge

  • Active knowledge concerning the premature infant

    one month after discharge

Study Arms (2)

Control group

NO INTERVENTION

The control group includes hospital consultations (usual care) on the hospital 2-3 times a week (1-2 hours) and the possibility to call the neonatal ward 24 hours a day all week until the infant gets full nutrition from the breast or bottle and gains weight. The parents register nutrition on a paper between the visits to the hospital.

App group/intervention group

EXPERIMENTAL

The intervention group will receive the Smartphone application at inclusion time and learn to use it in the hos-pital. When the families go home they will use the application and receive planned video consultations 2-3 times a week and the possibility to call the neonatal ward 24 hours a day all week whenever needed, until the infant gets full nutrition from the breast or bottle and gains weight. Parents will borrow a baby weight to weigh the baby at home.

Other: App group

Interventions

App groupOTHER
App group/intervention group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Infants who fulfil criteria for early in-home care. GA \> 34+0, No need for monitoring, tube feeding and started breastfeeding/bottle feeding, Danish speaking or English speaking patients (but understand the Danish text in the application).

You may not qualify if:

  • Infants who do not fulfil criteria for early in-home care and parents, who require extra observation of the par-ent-infant relationship.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Herning Neonatal

Herning, 7400, Denmark

Location

Neonatal

Næstved, 4700, Denmark

Location

Neonatal

Roskilde, 4000, Denmark

Location

Neonatal

Viborg, 8800, Denmark

Location

Related Publications (2)

  • Hagi-Pedersen MB, Dessau RB, Norlyk A, Stanchev H, Kronborg H. Comparison of video and in-hospital consultations during early in-home care for premature infants and their families: A randomised trial. J Telemed Telecare. 2022 Jan;28(1):24-36. doi: 10.1177/1357633X20913411. Epub 2020 Mar 30.

    PMID: 32228143DERIVED

  • Hagi-Pedersen MB, Norlyk A, Dessau R, Stanchev H, Kronborg H. Multicentre randomised study of the effect and experience of an early inhome programme (PreHomeCare) for preterm infants using video consultation and smartphone applications compared with inhospital consultations: protocol of the PreHomeCare study. BMJ Open. 2017 Mar 9;7(3):e013024. doi: 10.1136/bmjopen-2016-013024.

    PMID: 28279994DERIVED

MeSH Terms

Conditions

Premature BirthBreast Feeding

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFeeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MSN, ICU nurse, phd student

Study Record Dates

First Submitted

October 19, 2015

First Posted

October 21, 2015

Study Start

November 1, 2015

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

October 12, 2018

Record last verified: 2018-10

Locations

DK(4)