Positive Feeding of the Preterm Infant

NCT ID: NCT06189352

Last Updated: 2025-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-14

Study Completion Date

2026-05-31

Brief Summary

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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

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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.

Conditions

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Preterm Infant Breast Feeding Bottle Feeding Enteral Feeding Cue Based Feeding Develomentally Supportive Care

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Feasibility
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention group

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.

Group Type EXPERIMENTAL

Positive feeding of the preterm infant

Intervention Type OTHER

Feeding strategy for the preterm infant with description of nutritional needs and based on the infants development and cues.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oslo Metropolitan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nina M Kyno, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo Metropolitan University

Locations

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Vestre Viken Hospital Trust

Drammen, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Nina M Kyno, PhD

Role: CONTACT

+4790561929

Linn J Gustavsen, MSc

Role: CONTACT

+4797161225

Facility Contacts

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Bente Silnes Tandberg, PHD

Role: primary

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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551058

Identifier Type: -

Identifier Source: org_study_id

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