Positive Feeding of the Preterm Infant

Breast Feeding Clinical Trial

— PoP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06189352
• Other study ID #: 551058
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: May 2026

Study information

• Verified date: November 2023
• Source: Oslo Metropolitan University
• Contact: Nina M Kyno, PhD
• Phone: +4790561929
• Email: ninam[@]oslomet.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: May 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bottle Feeding
• Breast Feeding
• Enteral Feeding
• Premature Birth
• Preterm Infant

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Oslo Metropolitan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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