Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06305052
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-13
First Post:
2024-02-09
Brief Title:
Effects of Olfactory and Gustatory Stimulus on the Nutrition of Premature Babies
Sponsor:
Professor Fernando Figueira Integral Medicine Institute
Organization:
Professor Fernando Figueira Integral Medicine Institute
Study Overview
Official Title:
Effects of Olfactory and Gustatory Stimulus on the Nutrition of Premature Babies Double-blind Randomized Clinical Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 newborns tongue if they are awake or on their lips if they are sleeping and is performed immediately before tube feeding
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 newborns 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 IMIPMethods a double-blind randomized clinical trial will be carried out in premature infants receiving enteral feeding via an oronasogastric 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 andor weighing or equal to 1500g and who are indicated for feeding through a nasoorogastric 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 oralnasal 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
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 IMIPMethods a double-blind randomized clinical trial will be carried out in premature infants receiving enteral feeding via an oronasogastric 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 andor weighing or equal to 1500g and who are indicated for feeding through a nasoorogastric 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 oralnasal 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 65635922000005201 | OTHER | CAAE Certificate of Presentation of Ethical Review | None |