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

Premature Birth Clinical Trial

Official title:

Effects of Olfactory and Gustatory Stimulus on the Nutrition of Premature Babies: Double-blind Randomized Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06305052
• Other study ID #: estimulation-taste-olfactory
• Secondary ID: 65635922.0.0000.
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 4, 2023
• Est. completion date: April 2024

Study information

• Verified date: March 2024
• Source: Professor Fernando Figueira Integral Medicine Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 63
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 28 Weeks to 32 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Premature Birth

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Instituto de Medicina Integral Professor Fernando Figueira	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Professor Fernando Figueira Integral Medicine Institute

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Describe the gestational age of the newborn	This information will be collected from the newborn's medical record. Data regarding the gestational age of the newborn will be expressed in weeks.	until the moment of data collection from the medical records, which is equivalent to 1 day.
Secondary	Describe the sex of the newborn.	This information will be collected from the newborn's medical record. Data regarding the sex of the newborn will be expressed as female or male.	until the moment of data collection from the medical records, which is equivalent to 1 day.
Secondary	Describe the type of birth.	This information will be collected from the newborn's medical record. Data regarding the type of birth will be expressed as vaginal or cesarean section.	until the moment of data collection from the medical records, which is equivalent to 1 day.
Secondary	Describe the APGAR score.	This information will be collected from the newborn's medical record. The data regarding the APGAR score will be expressed in positive natural numbers from 0 to 10 in the first and fifth minutes of the newborn's life.	until the moment of data collection from the medical records, which is equivalent to 1 day.
Secondary	Describe birth weight and birth weight z-score.	The data will initially be checked in the medical record to obtain anthropometric parameters at birth: weight will be expressed in grams. The data obtained will be used in the Fenton 2013 calculator tool to obtain the zscores.	until the moment of data collection from the medical records, which is equivalent to 1 day.
Secondary	Describe head circumference at birth and head circumference z-score at birth	The data will initially be checked in the medical record to obtain anthropometric parameters at birth: the head circumference will be expressed in centimeters. The data will then be used in the Fenton 2013 calculator tool to obtain zscores.	until the moment of data collection from the medical records, which is equivalent to 1 day.
Secondary	Describe birth length and birth length z-score.	The data will initially be checked in the medical record to obtain anthropometric parameters at birth: length will be expressed in centimeters. The data will then be used in the Fenton 2013 calculator tool to obtain the zscores.	until the moment of data collection from the medical records, which is equivalent to 1 day.
Secondary	Determine the frequency of rupture of membranes >24h, chorioamnionitis, antepartum hemorrhage, gestational hypertension, pre-eclampsia and prenatal steroids >24h.	This information will be collected from the newborn's medical record. They will be noted on a specific form created by the researchers to demonstrate, through alternatives between yes or no, the presence of these variables.	at the time of data collection from the medical record, which is equivalent to 1 day.
Secondary	Compare the time, in days, of feeding via oral/nasal gastric tube.	The number of days that the newborn was fed through a tube will be recorded, using data provided in the medical record.	until the moment the tube feeding time will be recorded in days (evaluated up to 2 months).
Secondary	Compare the total duration, in days, of parenteral nutrition (TPN) use.	The number of days that the newborn was fed by parenteral nutrition will be recorded, using data provided in the medical record.	until the moment the time of parenteral nutrition feeding will be recorded in days (evaluated up to 15 days).
Secondary	Compare the type of food at discharge (natural, artificial or mixed).	The type of food that the newborn received during hospital discharge will be presented, whether it was natural with breast milk, artificial with the use of milk formulas or mixed when premature, it received both types of food. They will be obtained through data in the medical record.	until the moment when the type of food offered to the newborn upon discharge will be recorded (evaluated within 2 months).
Secondary	Compare weight gain and weight Z score, at 28 days of life and at discharge from the neonatal ICU, as well as anthropometric parameters: head circumference and length with their respective Z score at discharge from the NICU.	The data will initially be checked in the medical record to obtain anthropometric parameters: weight in grams, length in centimeters and head circumference in centimeters. The data will then be used in the Fenton 2013 calculator tool to obtain zscores.	until the newborn is 28 days old (assessed until the 28th) and at discharge (up to 2 months)
Secondary	Compare gestational age (GA) at the time of removal of the oro/nasogastric tube and at discharge from the NICU.	The gestational age data referring to the moment the newborn's tube was removed and at the time of discharge will be expressed in weeks. This data will be collected from the medical record.	until removal of the newborn's tube (assessed up to 2 months) and at discharge (up to 2 months)
Secondary	Compare the frequency of diagnosis of patent ductus arteriosus requiring treatment, bronchopulmonary dysplasia (BPD), retinopathy of prematurity, intraventricular hemorrhage and necrotizing enterocolitis.	This information will be collected from the newborn's medical record. They will be noted on a specific form prepared by the researchers to demonstrate, through alternatives between yes or no, the presence of these variables.	until the moment of discharge of the newborn (evaluated up to 2 months).
Secondary	Determine the association of treatment time with oxygen therapy (nasal catheter, nasal prong - nasal CPAP, intermittent positive pressure or endotracheal ventilation) in hours.	The medical record will check the treatment time in days, the treatment with oxygen therapy, whether it be (nasal catheter, nasal prong - nasal CPAP, intermittent positive pressure or endotracheal ventilation). After obtaining this data, the time will be transformed into hours and recorded on a specific research form.	until the moment of discharge of the newborn (assessed up to 2 months).