Breastfeeding Clinical Trial
Official title:
Effect and Experience of PreHomeCare of Preterm Infants Using Telecommunication and Smartphone Application: A Randomized Intervention Study.
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
Effect and experience of PreHomeCare of preterm infants using telecommunication and
Smartphone application: A randomized intervention study.
Premature infants and their patents are discharged earlier from hospital and sent home in
early in-homecare programs.
Effect studies of early in-homecare point towards that premature infants have lower risk of
infections under the period of tube feeding, higher parental satisfaction and indicate that
early in-homecare of premature infants benefit of home visits with fewer readmissions and
less unscheduled support, shorter length of hospital stay and longer provision of breast
milk. Standard procedure in early in-homecare is home visits but in regions of Denmark with
large distances to the parent/infant this is not possible. No studies have until now offered
24-7 hours home visit support. Further research regarding the use of health IT is needed to
say, whether the use of videoconference (participatory guidance) and Smartphone application
(knowledge and data registration) is a viable option to address the parents need for support
in relations to early discharge.
Main Study: A randomized controlled intervention study. The aim is to test the effect of the
use of video communication and mobile application on exclusive breastfeeding, parent/infant
interaction and parental confidence with the premature infants after PreHomeCare.
Hypothesis; Compared to parents of premature infants who receive hospital consultations, the
parents of premature infants who have access to electronic knowledge and participatory
guidance 24-7:
1. Increases proportion of exclusive breastfeeding.
2. Improves parent/infant interaction (MABISC-mother and baby interaction scale).
3. Enhances the families' feeling of confidence in caring for their infant (KPCS - Karitane
parenting confidence scale).
4. Increases parent's knowledge with regarding the premature infant and the care. Parents
will be randomized to either intervention or control group via simple randomization
procedure.
The intervention group will receive a mobile application and videoconference system. The
application contains three parts; 1) knowledge, 2) video contact/participatory guidance and
3) data registration.
Sample Size: Applying a significance level of 5%, a two-sided two-sample proportions test
revealed that a sample size of 39 in each group maintains a power of 80% to detect the
difference consisting of 55% vs. 40% breastfeeding women in the two groups after 4 weeks
conditional on 66% breastfeeding at discharge. This corresponds to a sample size of 65 at
randomisation. To compensate for the design effect ICC(0.01) the total sample size needed is
thus approximately 160 preterm infants, 80 in each group.
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 patents (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 observations of the parent-infant relationship.
Data analysis; the results of the intervention and control group will be compared and
analysed following "intention to treat" principle.
Qualitative evaluation:
Sub study 1: A field observational study: The aim is describe what characterizes nursing
practice in PreHomeCare from the parents' angle in home around video consultations. Method
will be based on Spradley "participant observation". The focus for the observation is the
nurses' communication, how is her act on the screen etc. The field observations are expected
to enlighten the characteristics of the nursing practice with a systematic description of
PreHomeCare setting using video consultations. The prose text will be analysed following
Ricoeur.
Sub study 2: An interview study: The aim is to explore how parents of premature infants
experience PreHomeCare with use of video communication and mobile application. The study will
be planned and conducted with inspiration from Kvale and Brinkmann´s instructions. The main
focus for the interview will be to uncover the main question: "How did you experience
PreHomeCare?" with a particular focus on what have been especially meaningful for the parents
under PreHomeCare. The verbatim transcribed material will be analysed following Ricoeur
interpretations theory.
Perspectives: This study will access new knowledge on the effect and experience with
PreHomeCare. It will give insight in what is needed to make clear goals for the quality of
the treatment and care for premature infants and parents in the last part of the
admission/PreHomeCare. It is expected that this project will be an argument in further
development of care for premature infants and telemedicine use in the future. The increased
effectiveness can address challenges and help relocate economic and professional health
services.
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