Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT06634329

Preterm Newborn's Behavioral Responses During Feeding 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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Premature Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Urogenital Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Pédiatrie - Hôpitaux Universitaires de Strasbourg

Strasbourg, 67 200, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oro or Nasogastric tube feeding

Other

Parental involvement in their premature baby's feeding

Primary outcomes

  1. 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.

Secondary outcomes

  1. - 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.

  2. - 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.

Interested in participating?

Not yet recruiting

Trial opening soon.

Get Notified

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Acronym: PREMALIM

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Oct 9, 2024
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.