Positive Feeding of the Preterm Infant

NCT06189352 | Recruiting

• 1 other identifier: 551058
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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.

  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,

  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

  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

  Prospective over a period of 1 year

Secondary Outcomes (1)

• Infant outcome variables

  Prospective over a period of 1 year

Study Arms (1)

Intervention group

EXPERIMENTAL

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

Interventions

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.

Intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo Metropolitan University: lead

Study Sites (1)

Vestre Viken Hospital Trust

Drammen, 3028, Norway

RECRUITING

MeSH Terms

Conditions

Premature Birth; Breast Feeding; Bottle Feeding

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Feeding Behavior; Behavior

Study Officials

• Nina M Kyno, PhD

  Oslo Metropolitan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nina M Kyno, PhD

CONTACT

+4790561929; ninam@oslomet.no

Linn J Gustavsen, MSc

CONTACT

+4797161225; linnjahr@oslomet.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: January 3, 2024
• Study Start: October 14, 2024
• Primary Completion: September 1, 2025
• Study Completion: May 1, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)