Breastfeeding Clinical Trial
Official title:
Effect and Experience of PreHomeCare of Preterm Infants Using Telecommunication and Smartphone Application: A Randomized Intervention Study.
NCT number | NCT02581800 |
Other study ID # | PreHomeCare |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2015 |
Est. completion date | October 2018 |
Verified date | October 2018 |
Source | Naestved Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 186 |
Est. completion date | October 2018 |
Est. primary completion date | October 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - 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). Exclusion Criteria: - Infants who do not fulfil criteria for early in-home care and parents, who require extra observation of the par-ent-infant relationship. |
Country | Name | City | State |
---|---|---|---|
Denmark | Herning Neonatal | Herning | |
Denmark | Neonatal | Næstved | |
Denmark | Neonatal | Roskilde | |
Denmark | Neonatal | Viborg |
Lead Sponsor | Collaborator |
---|---|
Mai-Britt Hägi-Pedersen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of breastfeeding | one month after discharge | ||
Secondary | Parents feeling of confidence | one month after discharge | ||
Secondary | Parent/child interaction | one month after discharge | ||
Secondary | Active knowledge concerning the premature infant | one month after discharge |
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