Preterm Newborn's Behavioral Responses During Feeding With Gastric Tube (PREMALIM)

October 8, 2024 updated by: University Hospital, Strasbourg, France

Assessment of the Comfort of Preterm Newborns During Feeding, Comparison of Different Methods of Milk Administration With Gastric Tube

Preterm infants need aims of a tube named oral or naso gastric to grow until they acquire autonomy in suction-swallowing.

In fact, several modes feed by a gastric tube exist : using an electric syringe pump (continuous administration), or manual and individualization administration. In this second case, milk can be delivered by gravity, depending on the height the syringe is placed above the infant, or by manually pushing on the syringe. Milk can be administrated by nurses or by the parents after a learning period.

In this observational study, we would like to compare the preterm infants' behavioral during these different naso or oro gastric feeding modes by observing well-being signs and withdrawal signs (Dsilna grid) on video settings.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Strasbourg, France, 67 200
        • Service de Pédiatrie - Hôpitaux Universitaires de Strasbourg
        • Sub-Investigator:
          • Pierre KUHN
        • Contact:
        • Contact:
        • Principal Investigator:
          • Claire ZORES
        • Sub-Investigator:
          • Clara SANCHIS
        • Sub-Investigator:
          • Laurence LANGLET MUTEAU
        • Sub-Investigator:
          • Elodie DILLENSEGER

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Newborn infants needing nasogastric tube feeding hospitalized at Rénaimation et médecine du nouveau né / University Hospital of Strasbourg

Description

Inclusion Criteria:

  • Hospitalized at the University Hospitals of Strasbourg during October 2024 and October 2025
  • Needing nasogastric tube feeding during at least 4 days
  • With parents (legal representants) having expressed their agreement with the use of video recording in the framework of the current study

Exclusion Criteria:

  • ORL malformations
  • Neurological dysfunction
  • Sedated infant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparing the tolerance of these different types of food (gravity versus pushing the seringue), based on the child's behavioral and physiological signs of well-being.
Time Frame: 6 months
Observation of preterm infants during and after naso/oro gastric tube feeding on videos to record well-being and withdrawal signs like classified in the Dsilna grid every 4 minutes.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
- Well-being and withdrawal signs by the Dsilna grid : comparison of manual methods versus electric syringe administration
Time Frame: 6 monts
Comparaison of the score of withdrawal or well being tube in this different situation. Survey to assess the feelings and experiences about feeding, filled by caregivers and parents.
6 monts
- Well-being and withdrawal signs by the Dsilna grid : comparison during administration by parents or nurses
Time Frame: 6 monts
Comparaison of the score of withdrawal or well being tube in this different situation. Survey to assess the feelings and experiences about feeding, filled by caregivers and parents.
6 monts

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Claire ZORES, Service de Pédiatrie, CHU de Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2024

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

October 7, 2024

First Submitted That Met QC Criteria

October 8, 2024

First Posted (Estimated)

October 9, 2024

Study Record Updates

Last Update Posted (Estimated)

October 9, 2024

Last Update Submitted That Met QC Criteria

October 8, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE-2024-56

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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