Effects of Olfactory and Gustatory Stimulus on the Nutrition of Premature Babies

NCT06305052 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2024-03-13

No results posted yet for this study

Summary

The objective of this clinical trial is to test the effects of olfactory and taste stimulation with milk or water in premature newborns with a gestational age between 28 and 32 weeks.

The main question researchers want to resolve is: • Does olfactory and gustatory stimulation in these newborns reduce the time spent with an oral or nasogastric feeding tube and bring forward oral feeding? Participants will be stimulated with milk or water depending on the randomly chosen group. 1: the olfactory stimulus (with smell) will be performed with a sterile cotton swab close to the nostrils immediately before feeding through the tube, 2: the gustatory stimulus (taste) will be performed with a sterile cotton swab on which a drop of milk or water will be applied on the newborn's tongue if they are awake or on their lips if they are sleeping, and is performed immediately before tube feeding.

Conditions

  • Weight, Birth
  • Premature Birth

Interventions

OTHER

Milk

Premature newborns allocated to the intervention group will receive olfactory and taste stimuli immediately before feeding through an oral/nasal gastric tube. In the intervention group, the taste stimulus will be carried out through a drop of milk administered directly to the tongue of the premature baby if he is awake, if the newborn is sleeping the milk will be placed on his lips. The olfactory stimulus will be offered through a drop of milk using a cotton swab, positioned close to the premature baby's nostrils as close as possible without touching them, immediately before the tube diet.

OTHER

Water

In the control group, the taste stimulus will be done through a drop of double-distilled water on a cotton swab, then administered directly to the tongue of the premature baby if he is awake, however, when he is sleeping, the drop of water will be deposited on his lips. The olfactory stimulus in the control group will be carried out with a drop of double-distilled water using a cotton swab, positioned close to the nostrils as close as possible without touching them, immediately before carrying out the tube diet.

Sponsors & Collaborators

  • Professor Fernando Figueira Integral Medicine Institute

    lead OTHER

Principal Investigators

  • João GB Alves, PhD · Instituto de Medicina Integral Fernando Figueira IMIP

  • Luana GR Fonseca · Instituto de Medicina Integral Fernando Figueira IMIP

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
28 Weeks
Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-04
Primary Completion
2024-04-30
Completion
2024-04-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06305052 on ClinicalTrials.gov