protocolSection identificationModule nctId: NCT06305052, orgStudyIdInfo id: estimulation-taste-olfactory, secondaryIdInfos id: 65635922.0.0000.5201, type: OTHER, domain: CAAE (Certificate of Presentation of Ethical Review), briefTitle: Effects of Olfactory and Gustatory Stimulus on the Nutrition of Premature Babies, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-04-04, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-04, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Professor Fernando Figueira Integral Medicine Institute, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Weight, Birth, conditions: Premature Birth, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 63, type: ACTUAL, armsInterventionsModule interventions name: Milk, interventions name: Water, outcomesModule primaryOutcomes measure: Comparison of the period between the beginning of the intervention and enteral feeding., secondaryOutcomes measure: Describe the gestational age of the newborn, secondaryOutcomes measure: Describe the sex of the newborn., secondaryOutcomes measure: Describe the type of birth., secondaryOutcomes measure: Describe the APGAR score., secondaryOutcomes measure: Describe birth weight and birth weight z-score., secondaryOutcomes measure: Describe head circumference at birth and head circumference z-score at birth, secondaryOutcomes measure: Describe birth length and birth length z-score., secondaryOutcomes measure: Determine the frequency of rupture of membranes >24h, chorioamnionitis, antepartum hemorrhage, gestational hypertension, pre-eclampsia and prenatal steroids >24h., secondaryOutcomes measure: Compare the time, in days, of feeding via oral/nasal gastric tube., secondaryOutcomes measure: Compare the total duration, in days, of parenteral nutrition (TPN) use., secondaryOutcomes measure: Compare the type of food at discharge (natural, artificial or mixed)., secondaryOutcomes 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., secondaryOutcomes measure: Compare gestational age (GA) at the time of removal of the oro/nasogastric tube and at discharge from the NICU., secondaryOutcomes measure: Compare the frequency of diagnosis of patent ductus arteriosus requiring treatment, bronchopulmonary dysplasia (BPD), retinopathy of prematurity, intraventricular hemorrhage and necrotizing enterocolitis., secondaryOutcomes measure: Determine the association of treatment time with oxygen therapy (nasal catheter, nasal prong - nasal CPAP, intermittent positive pressure or endotracheal ventilation) in hours., eligibilityModule sex: ALL, minimumAge: 28 Weeks, maximumAge: 32 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: Instituto de Medicina Integral Professor Fernando Figueira, city: Recife, state: Pernambuco, zip: 50070-550, country: Brazil, geoPoint lat: -8.05389, lon: -34.88111, hasResults: False