Oral Feeding Skills of Very Premature Infants (NUTRIO)

January 29, 2025 updated by: Hospices Civils de Lyon

Evaluation of Oral Feeding Skills of Very Premature Infants

Extremely premature infants, born at a gestational age (GA) of less than 29 weeks, are exposed to numerous complications in the neonatal period (digestive, cardiac, infectious, respiratory, neurological) and in the longer term (neurosensory and cognitive development, impaired growth, oral feeding disorders). In premature babies, non-nutritive sucking is present from 27 weeks' gestation, but the "suck, swallow, breathe" sequence, which is essential for feeding autonomy, does not mature until 34 weeks, with wide individual variations. Therefore, preterm newborns initially needs a gastric tube to receive enteral nutrition. During this period, the oral sphere is often dys-stimulated by the insertion/attachment of the gastric tube, aspirations of oral secretions, etc. The earlier children are born, the more frequent and serious the pathologies associated with prematurity, the more frequent these dys-stimulations are and the longer enteral feeding via gastric tube is required. As a result, the more immature the child, the more the development of oral performance is disrupted. This disrupts the transition from enteral feeding to oral feeding and therefore the acquisition of autonomous feeding, which is essential if the child is to be able to go out at home. This has an impact on the length of hospitalisation. Individualised developmental care, the current standard of care in neonatology, aims on the one hand to reduce dys-stimulation and on the other hand to offer positive oral stimulation such as non-nutritive sucking and perioral stimulation. Non-nutritive sucking consists of providing the child with a dummy as often and for as long as possible, i.e. as soon as the child is awake. Some departments also use specific and adapted perioral stimulation protocols. For several years, the department of neonatology at the Croix Rousse University Hospital included in care protocols, a protocol for peri-oral stimulation. It begins as soon as the baby is no longer suffering from any major (haemodynamic or respiratory) problems. It is stopped when feeding is active and autonomy has been achieved. It consists of stimulating the perioral and oral area, ideally four times a day, when the child is awake and particularly before meals. Perioral stimulation is performed on the baby's face, then, depending on the baby's reactions, oral stimulation is performed using a cotton bud soaked in milk. When the baby places his tongue in the sucking position and closes his lips, oral feeding can begin.

In a retrospective, single-centre study carried out in neonatology at the Croix Rousse hospital in 163 babies born before 29 weeks' gestation, the investigator calculated that the average corrected GA for the acquisition of feeding autonomy was 38.3 weeks' gestation, with significant inter-individual variability.

The hypothesis is that extremely premature infants already have oral skills very early, then lose them due to the numerous dys-stimulations of the oral sphere during intensive care period. Stimulations of the oral and perioral sphere, implemented early, could make it possible to limit this loss of competence and to observe a physiological evolution of oral skills.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

40

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 Locations

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

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Infants born before 29 GA (extreme prematurity), hospitalized in the Neonatal unit of Croix Rousse Hospital.

Description

Inclusion Criteria:

  • Infant born before 29 GA
  • Hospitalized in the Croix Rousse neonatology department
  • Admitted within the first three days of life

Exclusion Criteria:

  • Discharge (transfer) planned within 15 days of birth
  • Silicone allergy
  • Severe congenital malformation
  • Pathology requiring surgery
  • Parental refusal

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Extremely preterm infants
Extremely preterm infants born before 29 weeks.
Other: Succiometry
Assessement of sucking performance by measuring pressures (suction, crushing) with a succiometer every 10 days. This instrument consists of a standard silicone teat for premature newborns, which is connected via two silicone tubes to pressure micro-sensors. These pressure sensors measure the child's sucking activity on the teat. This activity is characterised by suction and crushing movements. It is a non-nutritive sucking activity (no fluid is delivered). Sucking performance is recorded during a period of calm awakening of the infant and over a period of 5 minutes, and is part of routine care since non-nutritive sucking is a common practice in neonatal unit. The first measurement will be taken in the first week of life and then every 7-10 days until discharge from the neonatal unit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Suckling performances
Time Frame: From date of inclusion until the date of discharge from the neonatal unit, assessed up to 5 months
The pressure variations recorded when the infant has the teat in its mouth are analysed. Various parameters are quantified to assess suckling performances: 1 - the number of suction peaks.
From date of inclusion until the date of discharge from the neonatal unit, assessed up to 5 months
Suckling performances
Time Frame: From date of inclusion until the date of discharge from the neonatal unit, assessed up to 5 months
The pressure variations recorded when the infant has the teat in its mouth are analysed. Various parameters are quantified to assess suckling performances: 2 - the amplitude of suction peaks.
From date of inclusion until the date of discharge from the neonatal unit, assessed up to 5 months
Suckling performances
Time Frame: From date of inclusion until the date of discharge from the neonatal unit, assessed up to 5 months
The pressure variations recorded when the infant has the teat in its mouth are analysed. Various parameters are quantified to assess suckling performances: 3 - the timing of suction peaks.
From date of inclusion until the date of discharge from the neonatal unit, assessed up to 5 months
Suckling performances
Time Frame: From date of inclusion until the date of discharge from the neonatal unit, assessed up to 5 months
The pressure variations recorded when the infant has the teat in its mouth are analysed. Various parameters are quantified to assess suckling performances: 4 - the number of crushing peaks.
From date of inclusion until the date of discharge from the neonatal unit, assessed up to 5 months
Suckling performances
Time Frame: From date of inclusion until the date of discharge from the neonatal unit, assessed up to 5 months
The pressure variations recorded when the infant has the teat in its mouth are analysed. Various parameters are quantified to assess suckling performances: 5 - the amplitude of crushing peaks.
From date of inclusion until the date of discharge from the neonatal unit, assessed up to 5 months
Suckling performances
Time Frame: From date of inclusion until the date of discharge from the neonatal unit, assessed up to 5 months
The pressure variations recorded when the infant has the teat in its mouth are analysed. Various parameters are quantified to assess suckling performances: 6 - the timing of crushing peaks.
From date of inclusion until the date of discharge from the neonatal unit, assessed up to 5 months

Collaborators and Investigators

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

Sponsor

Hospices Civils de Lyon

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 (Actual)

December 17, 2024

Primary Completion (Estimated)

May 17, 2026

Study Completion (Estimated)

May 17, 2026

Study Registration Dates

First Submitted

October 16, 2024

First Submitted That Met QC Criteria

October 23, 2024

First Posted (Actual)

October 24, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 29, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL24_0741
  • 2024-A01791-46 (Other Identifier: ID RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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