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Preterm Newborn's Behavioral Responses During Feeding With Gastric Tube

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06634329
Acronym
PREMALIM
Enrollment
50
Registered
2024-10-09
Start date
2024-11-30
Completion date
2025-11-30
Last updated
2024-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Birth

Keywords

Preterm infants, Oro/nasogastric tube feeding, Developmental care, Parents integration

Brief summary

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.

Interventions

OTHEROro or Nasogastric tube feeding

Parental involvement in their premature baby's feeding

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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.6 monthsObservation 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

MeasureTime frameDescription
- Well-being and withdrawal signs by the Dsilna grid : comparison of manual methods versus electric syringe administration6 montsComparaison 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.
- Well-being and withdrawal signs by the Dsilna grid : comparison during administration by parents or nurses6 montsComparaison 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.

Countries

France

Contacts

Primary ContactClaire ZORES
claire.zores@chru-strasbourg.fr+33 3 88 12 83 32
Backup ContactClara SANCHIS
mailto:clara.sanchis@chru-strasbourg.fr0634139100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026