An interventional study of Positive feeding of the preterm infant in Preterm Infant, Breast Feeding and Bottle Feeding, sponsored by Oslo Metropolitan University. Recruiting at 1 site in Norway. Per ClinicalTrials.gov, last updated 2025-08-11.
Sponsored by Oslo Metropolitan University · Not applicable, Interventional, and Supportive care
The goal of this feasibility study is to assess the feasibility to implement a feeding strategy for preterm infants.
The main questions it aims to answer are:
Parents of preterm infants and health care personnel will be asked to follow a protocol of a feeding strategy based on the preterm infants development and cues throughout the NICU-stay.
The parents will be recruited before or as soon as possible after birth. The intervention will start as soon as the parents have given written consent for themselves and behalf of their infant.
The intervention is developed in line with the MRC framework of developing and evaluating complex interventions in an iterative and dynamic way. The intervention will be based on parents counseling and an infant feeding protocol.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's planned enrollment of 15 is below the median of 84 across 1,666 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Oslo Metropolitan University is the lead sponsor of 64 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The infants will follow a feeding protocol with detailed nutritional needs, and individual supportive care interventions for enhancing oral feeding development. Parents will get counseling sessions for supporting this strategy. The protocol will follow the infant until discharge.
Other: Positive feeding of the preterm infant
Feeding strategy for the preterm infant with description of nutritional needs and based on the infants development and cues.
Recruitment rates and sample criteria
Variables to evaluate if we can recruit appropriate participants, the time frame it takes, the eligibility criterias, the recruitment routines.
Time frame: Prospective over a period of 1 year
Data collection and outcome variables
How appropriate are the data collection procedures, the participants ability to complete the quiestionnaires, appropriatness of the amount of data collection, completion of datasets,
Time frame: Prospective over a period of 1 year
Acceptability
Evaluation of acceptability of the intervention for the participants, adherence to the study procedures, the burden for participants and the health care personnell conducting the intervention, safety and adverse events
Time frame: Prospective over a period of 1 year
Resources and organisation
Evaluation of the resources needed to conduct the study procedures, resources needed for training health care personnel or other costs related to the study
Time frame: Prospective over a period of 1 year
Infant outcome variables
A pilotstudy of the intervention with focus on the infants outcomes, such as weight gain, feeding milestones, nutrition, feeding methods,
Time frame: Prospective over a period of 1 year
Plan to share: No
Started Oct 2024 (actual). Primary completion is estimated for Sep 2025, 11 months after the start.
Of 741 non-industry interventional studies with no phase under Premature Birth, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 11 months is below that.
Counting every sponsor, half of 759 studies reached it within 24 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
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Oslo Metropolitan University