Skip to content

Positive Feeding of the Preterm Infant

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06189352
Acronym
PoP
Enrollment
15
Registered
2024-01-03
Start date
2024-10-14
Completion date
2026-05-31
Last updated
2025-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

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.

Interventions

OTHERPositive feeding of the preterm infant

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

Sponsors

Oslo Metropolitan University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Feasibility

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Recruitment rates and sample criteriaProspective over a period of 1 yearVariables to evaluate if we can recruit appropriate participants, the time frame it takes, the eligibility criterias, the recruitment routines.
Data collection and outcome variablesProspective over a period of 1 yearHow appropriate are the data collection procedures, the participants ability to complete the quiestionnaires, appropriatness of the amount of data collection, completion of datasets,
AcceptabilityProspective over a period of 1 yearEvaluation 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
Resources and organisationProspective over a period of 1 yearEvaluation of the resources needed to conduct the study procedures, resources needed for training health care personnel or other costs related to the study

Secondary

MeasureTime frameDescription
Infant outcome variablesProspective over a period of 1 yearA pilotstudy of the intervention with focus on the infants outcomes, such as weight gain, feeding milestones, nutrition, feeding methods,

Countries

Norway

Contacts

Primary ContactNina M Kyno, PhD
ninam@oslomet.no+4790561929
Backup ContactLinn J Gustavsen, MSc
linnjahr@oslomet.no+4797161225

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026