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

NCT06305052 | Active Not Recruiting

• 2 other identifiers: estimulation-taste-olfactory65635922.0.0000.5201
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Nutrition; Prematurity; human milk; smell and taste

Outcome Measures

Primary Outcomes (1)

• Comparison of the period between the beginning of the intervention and enteral feeding.

  Comparison of the period between the beginning of the intervention and the completion of enteral feeding (removal of the oral or nasogastric tube), verified through the number of days in the period. will be verified in the newborn's medical record.

  until the moment when the newborn's oral or nasal gastric tube will be removed (evaluated up to 1 month).

Secondary Outcomes (15)

• Describe the gestational age of the newborn

  until the moment of data collection from the medical records, which is equivalent to 1 day.

• Describe the sex of the newborn.

  until the moment of data collection from the medical records, which is equivalent to 1 day.

• Describe the type of birth.

  until the moment of data collection from the medical records, which is equivalent to 1 day.

• Describe the APGAR score.

  until the moment of data collection from the medical records, which is equivalent to 1 day.

• Describe birth weight and birth weight z-score.

  until the moment of data collection from the medical records, which is equivalent to 1 day.

Study Arms (2)

Milk group

EXPERIMENTAL

Olfactory and gustatory stimuli with milk in premature infants before tube feeding.

Other: Milk

Placebo group

PLACEBO COMPARATOR

Olfactory and taste stimuli with double-distilled water in premature infants before tube feeding

Other: Water

Interventions

Milk OTHER

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.

Milk group

Water OTHER

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.

Placebo group

Eligibility Criteria

• Age: 28 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Newborns with Gestational Age (GA) between 28 and 32 weeks and/or birth weight ≤1,500g.
• Use of oro/nasogastric tube.

You may not qualify if:

• Newborns who have already started enteral feeding
• Twin newborns
• Congenital malformation associated with the digestive system that requires surgery soon after birth.
• Congenital conditions that impair growth

Sponsors & Collaborators

• Professor Fernando Figueira Integral Medicine Institute: lead

Study Sites (1)

Instituto de Medicina Integral Professor Fernando Figueira

Recife, Pernambuco, 50070-550, Brazil

Location

MeSH Terms

Conditions

Birth Weight; Premature Birth; Anosmia

Interventions

Milk; Water

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• João GB Alves, PhD

  Instituto de Medicina Integral Fernando Figueira IMIP

  STUDY DIRECTOR

• Luana GR Fonseca

  Instituto de Medicina Integral Fernando Figueira IMIP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: March 12, 2024
• Study Start: April 4, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

BR (1)