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Clinical Trials/NCT06189352
NCT06189352
Recruiting
Not Applicable

Positive Feeding of the Preterm Infant - a Feasibility Study of a Developmental Supportive Feeding Strategy in the NICU

Oslo Metropolitan University1 site in 1 country15 target enrollmentOctober 14, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preterm Infant
Sponsor
Oslo Metropolitan University
Enrollment
15
Locations
1
Primary Endpoint
Recruitment rates and sample criteria
Status
Recruiting
Last Updated
8 months ago

Overview

Brief Summary

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:

  • Is it feasible to implement the PoP-intervention in a level 3a category Neonatal intensive care unit?
  • Is the PoP-intervention acceptable for parents of preterm infants and health care personnel working in Neonatal intensive care unit?

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
October 14, 2024
End Date
May 1, 2026
Last Updated
8 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Oslo Metropolitan University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • gestational age of 28 weeks
  • post menstrual age of 28 weeks after transition from regional hospital

Exclusion Criteria

  • diagnoses or malformations that makes eating difficult
  • triplets or more
  • parents not speaking/understanding Norwegian or English
  • parents with challenges or special needs for follow up

Outcomes

Primary Outcomes

Recruitment rates and sample criteria

Time Frame: Prospective over a period of 1 year

Variables to evaluate if we can recruit appropriate participants, the time frame it takes, the eligibility criterias, the recruitment routines.

Acceptability

Time Frame: Prospective over a period of 1 year

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

Data collection and outcome variables

Time Frame: Prospective over a period of 1 year

How appropriate are the data collection procedures, the participants ability to complete the quiestionnaires, appropriatness of the amount of data collection, completion of datasets,

Resources and organisation

Time Frame: Prospective over a period of 1 year

Evaluation of the resources needed to conduct the study procedures, resources needed for training health care personnel or other costs related to the study

Secondary Outcomes

  • Infant outcome variables(Prospective over a period of 1 year)

Study Sites (1)

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