Preterm Newborn's Behavioral Responses During Feeding With Gastric Tube

NCT06634329 | Not Yet Recruiting

• 1 other identifier: CE-2024-56
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth

Keywords

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

Outcome Measures

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.

  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 Outcomes (2)

• - Well-being and withdrawal signs by the Dsilna grid : comparison of manual methods versus electric syringe administration

  6 monts

• - Well-being and withdrawal signs by the Dsilna grid : comparison during administration by parents or nurses

  6 monts

Interventions

Oro or Nasogastric tube feeding OTHER

Parental involvement in their premature baby's feeding

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• ORL malformations
• Neurological dysfunction
• Sedated infant

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de Pédiatrie - Hôpitaux Universitaires de Strasbourg

Strasbourg, 67 200, France

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Study Officials

• Claire ZORES

  Service de Pédiatrie, CHU de Strasbourg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claire ZORES

CONTACT

+33 3 88 12 83 32; claire.zores@chru-strasbourg.fr

Clara SANCHIS

CONTACT

0634139100; mailto:clara.sanchis@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 9, 2024
• Study Start: November 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2025
• Last Updated: October 9, 2024

Record last verified: 2024-10

Locations

FR (1)