Menu
Recruiting NCT06189352

Positive Feeding of the Preterm Infant

No phase Interventional Preterm Infant Breast Feeding Bottle Feeding Enteral Feeding

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Positive feeding of the preterm infant.
Who it may be relevant to
Registry conditions: Preterm Infant, Breast Feeding, Bottle Feeding, Enteral Feeding. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • 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.

Primary outcome measures

  • Recruitment rates and sample criteria [Time frame: Prospective over a period of 1 year]
  • Data collection and outcome variables [Time frame: Prospective over a period of 1 year]
  • Acceptability [Time frame: Prospective over a period of 1 year]
  • Resources and organisation [Time frame: Prospective over a period of 1 year]
Secondary outcome measures (1)
  • Infant outcome variables [Time frame: Prospective over a period of 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

Norway · 1 center
  • Vestre Viken Hospital Trust — Drammen

Identifiers

NCT: NCT06189352 · 551058

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗