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NCT Number: NCT06189352

Positive Feeding of the Preterm Infant

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.

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Key information

Conditions

Preterm Infant Behavior Bottle Feeding Breast Feeding Cue Based Feeding Develomentally Supportive Care Enteral Feeding Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vestre Viken Hospital Trust

Drammen, 3028, Norway

Location status: Recruiting

Location contact

Bente Silnes Tandberg, PHD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Positive feeding of the preterm infant

Other

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

Primary outcomes

  1. 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.

  2. 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,

  3. 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

  4. 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

  1. Infant outcome variables

    Time frame: 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,

Study contacts

Contact information is provided by the study sponsor or research team.

Linn J Gustavsen, MSc

CONTACT

[email protected]

+4797161225

Nina M Kyno, PhD

CONTACT

[email protected]

+4790561929

Sponsors and collaborators

Lead sponsor

Oslo Metropolitan University

Other

Registry information

Official study title

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

Acronym: PoP

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 3, 2024
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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