Evaluation of Breastfeeding Support After Short Time Hospitalization
This study is currently recruiting participants.
Verified May 2013 by Danish Committee for Health Education
Sponsor:
Danish Committee for Health Education
Collaborator:
TrygFonden, Denmark
Information provided by (Responsible Party):
Ingrid Nilsson, Danish Committee for Health Education
ClinicalTrials.gov Identifier:
NCT01620723
First received: June 12, 2012
Last updated: May 6, 2013
Last verified: May 2013
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Purpose
The purpose of this study is to evaluate if the developed theory and evidence based programme has a positive effect on mother's breastfeeding self efficacy, establishing an effective breastfeeding and breastfeeding duration after short time hospitalization.
| Condition | Intervention |
|---|---|
|
Breastfeeding |
Other: New Breastfeeding Counselling Other: Treatment as usual |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Effect Evaluation of a Theory and Evidence Based Programme for Establishing Effective Breastfeeding After Short Time Hospitalization Post Partum |
Resource links provided by NLM:
Further study details as provided by Danish Committee for Health Education:
Primary Outcome Measures:
- Parents breastfeeding self efficacy [ Time Frame: 7 days post partum ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Effective breastfeeding [ Time Frame: 7 days post partum ] [ Designated as safety issue: Yes ]Effective breastfeeding is measured by the outcome measures: breastfeeding frequency, milk coming in before 3rd day pp, number of stools 3 days pp, baby's swallowing of milk
- Duration of exclusive and full breastfeeding [ Time Frame: 7 and 30 days post partum and 6 month post partum ] [ Designated as safety issue: No ]
- Baby's morbidity [ Time Frame: 7 and 30 days post partum and 6 month post partum ] [ Designated as safety issue: Yes ]Measuring jaundice, dehydration, use of health facilities
- Breastfeeding problems [ Time Frame: 7 and 30days and 6 month post partum ] [ Designated as safety issue: No ]Measuring nipple pain and fissures, too much or too little milk
| Estimated Enrollment: | 1500 |
| Study Start Date: | May 2013 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: New breastfeeding counselling |
Other: New Breastfeeding Counselling
An intervention will be developed during the first part of the study. The intervention is supposed to consist of evidence based actions to support the metabolic adaptation of the newborn, establishment of the milk production of the mother and increase the breastfeeding self efficacy of the mother.
|
| Treatment as usual |
Other: Treatment as usual
Health professionals offer the usual care for the breastfeeding mother
|
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- pregnant women (gestational week 35-36)
Exclusion Criteria:
- women with known physical, psychological and/or social illness/problem that result in hospitalization more than 50 hours after delivery
- women with known pregnancy related illness that result in hospitalization more than 50 hours after delivery
- Women not understanding or speaking Danish
- women expecting multiple babies
- women having decided not to breastfeed
- women expecting to deliver at another hospital than the one she has been visiting during pregnancy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01620723
Locations
| Denmark | |
| Aalborg Sygehus | Recruiting |
| Aalborg, Denmark, 9000 | |
| Contact: Birgitte Meier Jensen bimej@rn.dk | |
| Sygehus Vendsyssel | Recruiting |
| Hjoerring, Denmark, 9800 | |
| Contact: Nina C Haumann +45 22625354 nch@rn.dk | |
| Horsens sygehus | Recruiting |
| Horsens, Denmark, 8700 | |
| Contact: Zena Esteitiyeh zenaesteitiyeh@yahoo.dk | |
| Kolding Sygehus | Recruiting |
| Kolding, Denmark, 6000 | |
| Contact: Janni Skovlund Janni.Skovshoved@slb.regionsyddanmark.dk | |
| Nykøbing F Sygehuse | Recruiting |
| Nykøbing F, Denmark, 4800 | |
| Contact: Helle Andersen hean@regionsjaelland.dk | |
| Regionshospitalet Randers | Recruiting |
| Randers, Denmark, 8900 | |
| Contact: Lone Neumann +45 78 42 11 03 loneneum@rm.dk | |
| Haderslev/Sønderborg sygehus | Recruiting |
| Sønderborg, Denmark, 6400 | |
| Contact: Annette Rabe +45 2895 2717 Annette.rabe@shs.regionsyddanmark.dk | |
| Sygehus Thy-Mors | Recruiting |
| Thisted, Denmark, 7700 | |
| Contact: Joan Immersen Kjeldsen +45 96 17 62 49 joan.kjeldsen@rn.dk | |
| Regionshospitalet Viborg | Recruiting |
| Viborg, Denmark, 8800 | |
| Contact: Lotte Thrige +45 78442520 Lotte.Thrige@rm.dk | |
Sponsors and Collaborators
Danish Committee for Health Education
TrygFonden, Denmark
Investigators
| Principal Investigator: | Ingrid Nilsson, RN, MSA, IBCLC | Danish Committee for Health Education |
More Information
No publications provided
| Responsible Party: | Ingrid Nilsson, Senior Project Coordinator, Danish Committee for Health Education |
| ClinicalTrials.gov Identifier: | NCT01620723 History of Changes |
| Other Study ID Numbers: | 7111442 |
| Study First Received: | June 12, 2012 |
| Last Updated: | May 6, 2013 |
| Health Authority: | Denmark: Danish Dataprotection Agency |
Keywords provided by Danish Committee for Health Education:
|
Breastfeeding Breastfeeding self efficacy |
ClinicalTrials.gov processed this record on May 22, 2013