Positive Feeding of the Preterm Infant

Not Applicable

Not yet recruiting

• Conditions: Enteral Feeding; Cue Based Feeding; Develomentally Supportive Care; Preterm Infant; Breast Feeding; Bottle Feeding
• Interventions: Other: Positive feeding of the preterm infant

• Registration Number: NCT06189352
• Lead Sponsor: Oslo Metropolitan University

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.

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-28
• Study First Submitted QC: 2023-12-19
• Last Update Submitted: 2023-12-19
• Study First Posted: 2024-01-03
• Last Update Posted: 2024-01-03
• Study Start: 2024-08
• Primary Completion: 2025-09
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention group	Positive feeding of the preterm infant	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.

Primary Outcome Measures

Name	Time	Method
Recruitment rates and sample criteria	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	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	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	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 Outcome Measures

Name	Time	Method
Infant outcome variables	Prospective over a period of 1 year	A pilotstudy of the intervention with focus on the infants outcomes, such as weight gain, feeding milestones, nutrition, feeding methods,