Clinical trial NCT06305052: Effects of Olfactory and Gustatory Stimulus on the Nutrition of Premature Babies
Official title: Effects of Olfactory and Gustatory Stimulus on the Nutrition of Premature Babies: Double-blind Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Weight, Birth
Premature Birth
Keywords: Nutrition
Prematurity
human milk
smell and taste
Lead sponsor: Professor Fernando Figueira Integral Medicine Institute
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 63
Sex: ALL
Minimum age (years): 28
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

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

Primary outcomes:
measure: Comparison of the period between the beginning of the intervention and enteral feeding.
timeFrame: until the moment when the newborn's oral or nasal gastric tube will be removed (evaluated up to 1 month).
Secondary outcomes:
measure: Describe the gestational age of the newborn
timeFrame: until the moment of data collection from the medical records, which is equivalent to 1 day.
measure: Describe the sex of the newborn.
timeFrame: until the moment of data collection from the medical records, which is equivalent to 1 day.
measure: Describe the type of birth.
timeFrame: until the moment of data collection from the medical records, which is equivalent to 1 day.
measure: Describe the APGAR score.
timeFrame: until the moment of data collection from the medical records, which is equivalent to 1 day.
measure: Describe birth weight and birth weight z-score.
timeFrame: until the moment of data collection from the medical records, which is equivalent to 1 day.
measure: Describe head circumference at birth and head circumference z-score at birth
timeFrame: until the moment of data collection from the medical records, which is equivalent to 1 day.
measure: Describe birth length and birth length z-score.
timeFrame: until the moment of data collection from the medical records, which is equivalent to 1 day.
measure: Determine the frequency of rupture of membranes >24h, chorioamnionitis, antepartum hemorrhage, gestational hypertension, pre-eclampsia and prenatal steroids >24h.
timeFrame: at the time of data collection from the medical record, which is equivalent to 1 day.
measure: Compare the time, in days, of feeding via oral/nasal gastric tube.
timeFrame: until the moment the tube feeding time will be recorded in days (evaluated up to 2 months).
measure: Compare the total duration, in days, of parenteral nutrition (TPN) use.
timeFrame: until the moment the time of parenteral nutrition feeding will be recorded in days (evaluated up to 15 days).
measure: Compare the type of food at discharge (natural, artificial or mixed).
timeFrame: until the moment when the type of food offered to the newborn upon discharge will be recorded (evaluated within 2 months).
measure: 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.
timeFrame: until the newborn is 28 days old (assessed until the 28th) and at discharge (up to 2 months)
measure: Compare gestational age (GA) at the time of removal of the oro/nasogastric tube and at discharge from the NICU.
timeFrame: until removal of the newborn's tube (assessed up to 2 months) and at discharge (up to 2 months)
measure: Compare the frequency of diagnosis of patent ductus arteriosus requiring treatment, bronchopulmonary dysplasia (BPD), retinopathy of prematurity, intraventricular hemorrhage and necrotizing enterocolitis.
timeFrame: until the moment of discharge of the newborn (evaluated up to 2 months).
measure: Determine the association of treatment time with oxygen therapy (nasal catheter, nasal prong - nasal CPAP, intermittent positive pressure or endotracheal ventilation) in hours.
timeFrame: until the moment of discharge of the newborn (assessed up to 2 months).
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Instituto de Medicina Integral Professor Fernando Figueira
state: Pernambuco
Study officials:
affiliation: Instituto de Medicina Integral Fernando Figueira IMIP
name: João GB Alves, PhD
role: STUDY_DIRECTOR
affiliation: Instituto de Medicina Integral Fernando Figueira IMIP
name: Luana GR Fonseca
role: PRINCIPAL_INVESTIGATOR
References: