Preterm InfantPoPNCT06189352
Positive Feeding of the Preterm Infant
A study testing Positive feeding of the preterm infant in people with Preterm Infant and Breast Feeding, run by Oslo Metropolitan University at 1 site in Norway.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Preterm Infant, Breast Feeding, Bottle Feeding
- What is being tested?
- Positive feeding of the preterm infant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNorway
- Study dates
- 14 Oct 2024to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- gestational age of 28 weeks
- post menstrual age of 28 weeks after transition from regional hospital
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Vestre Viken Hospital Trust
Drammen, 3028
Bente Silnes Tandberg, PHD
About this study
Official title: 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.
Read the 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.
- Conditions
- Preterm Infant, Breast Feeding, Bottle Feeding, Enteral Feeding, Cue Based Feeding, Develomentally Supportive Care
- Being tested
- Positive feeding of the preterm infant
- Medical subject headings
- Premature Birth, Breast Feeding, Bottle Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive feeding of the preterm infantOther
Feeding strategy for the preterm infant with description of nutritional needs and based on the infants development and cues.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Positive feeding of the preterm infant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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,
Measured: 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
Measured: 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
Measured: Prospective over a period of 1 year
Secondary outcomes (1)
Infant outcome variables
A pilotstudy of the intervention with focus on the infants outcomes, such as weight gain, feeding milestones, nutrition, feeding methods,
Measured: Prospective over a period of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start14 Oct 2024
- Primary completionSep 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nina M Kyno, PhD, Principal investigator, Oslo Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189352
- Sponsor's protocol ID
- 551058
- Acronym
- PoP
- Status last verified
- Mar 2025
- First submitted
- 28 Nov 2023
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Feeding of the Preterm Infant - a Feasibility Study of a Developmental Supportive Feeding Strategy in the NICU
- ClinicalTrials.gov ID
- NCT06189352
- Acronym / sponsor ID
- PoP / 551058
- Conditions
- Preterm Infant, Breast Feeding, Bottle Feeding, Enteral Feeding, Cue Based Feeding, Develomentally Supportive Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Positive feeding of the preterm infantThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- gestational age of 28 weeks
- post menstrual age of 28 weeks after transition from regional hospital
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive feeding of the preterm infantFeeding strategy for the preterm infant with description of nutritional needs and based on the infants development and cues. | Other | Intervention group |
Primary outcome
Recruitment rates and sample criteria
Time frame: Prospective over a period of 1 year
Variables to evaluate if we can recruit appropriate participants, the time frame it takes, the eligibility criterias, the recruitment routines.
Data collection and outcome variables
Time frame: Prospective over a period of 1 year
How appropriate are the data collection procedures, the participants ability to complete the quiestionnaires, appropriatness of the amount of data collection, completion of datasets,
Acceptability
Time frame: Prospective over a period of 1 year
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
Resources and organisation
Time frame: Prospective over a period of 1 year
Evaluation of the resources needed to conduct the study procedures, resources needed for training health care personnel or other costs related to the study
1 secondary outcome
Infant outcome variables
Time frame: Prospective over a period of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Preterm Infant
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nina M Kyno, PhD principal investigator
Oslo Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive feeding of the preterm infant in people with Preterm Infant and Breast Feeding, run by Oslo Metropolitan University at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nina M Kyno, PhD (+4790561929, ninam@oslomet.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rates and sample criteria (time frame: Prospective over a period of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.