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

NCT ID: NCT06305052

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-04
• Study Completion Date: 2024-04-30

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.

Detailed Description

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.

Prematurity is the main cause of infant morbidity and mortality in Brazil. Nutritional problems caused by digestive immaturity are generally associated with undesirable outcomes in preterm infants, both immediate and late, and improving preemies' tolerance to milk has been challenging. The cephalic phase of digestion plays a crucial role in nutrient absorption. However, although it is known that smell and taste develop during intrauterine life, olfactory and taste stimuli have not yet been properly studied in the nutrition of premature babies. Objectives: to determine the effects of olfactory and gustatory stimuli on the nutrition of premature infants admitted to the neonatal intensive care unit of the Instituto de Medicina Integral Prof. Fernando Figueira (IMIP).Methods: a double-blind randomized clinical trial will be carried out in premature infants receiving enteral feeding via an oro/nasogastric tube. The study will be carried out at the IMIP university hospital, Recife-Pernambuco. The population will be composed of premature babies with a gestational age between 28 and 32 weeks and/or weighing < or equal to 1,500g and who are indicated for feeding through a naso/orogastric tube. The intervention will consist of olfactory and taste stimuli through breast milk. The primary outcome will be considered the period defined in days from the beginning of stimulation until the removal of the nasal or orogastric tube. Secondary outcomes will be considered: weight gain and anthropometric parameters, such as weight, length and head circumference at discharge from the NICU, as well as feeding time via oral/nasal and parenteral gastric tube, type of feeding at the time of secretion (natural or artificial) and diagnosis of necrotizing enterocolitis. The study is characterized as a prospective randomized clinical trial, with a pragmatic sample size determined during the recruitment period established at 10 months. Analysis will be performed by intention to treat. This project must be previously approved by the IMIP Ethics Committee and all participants must have their parents sign the Free and Informed Consent Form

Conditions

Weight, Birth; Premature Birth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Milk group

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

Group Type: EXPERIMENTAL

Milk

Intervention Type: 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.

Placebo group

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

Group Type: PLACEBO_COMPARATOR

Water

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 28 Weeks
• Maximum Eligible Age: 32 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Professor Fernando Figueira Integral Medicine Institute

OTHER

Sponsor Role: lead

Responsible Party

João Guilherme Bezerra Alves

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

João GB Alves, PhD

Role: STUDY_DIRECTOR

Instituto de Medicina Integral Fernando Figueira IMIP

Luana GR Fonseca

Role: PRINCIPAL_INVESTIGATOR

Instituto de Medicina Integral Fernando Figueira IMIP

Locations

Instituto de Medicina Integral Professor Fernando Figueira

Recife, Pernambuco, Brazil

Countries

Brazil

Other Identifiers

65635922.0.0000.5201

Identifier Type: OTHER

Identifier Source: secondary_id

estimulation-taste-olfactory

Identifier Type: -

Identifier Source: org_study_id