Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive feeding of the preterm infant | Other | Feeding strategy for the preterm infant with description of nutritional needs and based on the infants development and cues. |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nina M Kyno, PhD | Contact | +4790561929 | ninam@oslomet.no | |
| Linn J Gustavsen, MSc | Contact | +4797161225 | linnjahr@oslomet.no |
| Name | Affiliation | Role |
|---|---|---|
| Nina M Kyno, PhD | Oslo Metropolitan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vestre Viken Hospital Trust | Recruiting | Drammen | 3028 | Norway |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 1, 2023 | Dec 19, 2023 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D001942 | Breast Feeding |
| D001903 | Bottle Feeding |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Feasibility
Not provided
Not provided
Not provided
Not provided
| D000091642 | Urogenital Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |