Positive Feeding of the Preterm Infant (PoP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Feeding; Enteral Feeding; Bottle Feeding; Preterm Infant; Cue Based Feeding; Develomentally Supportive Care
• Intervention / Treatment: Other: Positive feeding of the preterm infant

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 Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nina M Kyno, PhD; Phone Number: +4790561929; Email: ninam@oslomet.no
• Study Contact Backup: Name: Linn J Gustavsen, MSc; Phone Number: +4797161225; Email: linnjahr@oslomet.no

Study Locations

• Norway
  • Drammen, Norway, 3028
    • Recruiting
    • Vestre Viken Hospital Trust
    • Contact: Bente Silnes Tandberg, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Oslo Metropolitan University
• Investigators: Principal Investigator: Nina M Kyno, PhD, Oslo Metropolitan University

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: November 28, 2023
• First Submitted That Met QC Criteria: December 19, 2023
• First Posted (Actual): January 3, 2024

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth
• Other Study ID Numbers: 551058

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No