Weight, BirthNCT06305052
Effects of Olfactory and Gustatory Stimulus on the Nutrition of Premature Babies
A study testing Milk and Water in people with Weight, Birth and Premature Birth, run by Professor Fernando Figueira Integral Medicine Institute at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 28 to 32 weeksHealthy volunteers can take part
- Conditions the study is for
- Weight, Birth, Premature Birth
- What is being tested?
- Milk and Water
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteBrazil
- Study dates
- 4 Apr 2023to Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 32 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Newborns with Gestational Age (GA) between 28 and 32 weeks and/or birth weight ≤1,500g.
- Use of oro/nasogastric tube.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Medicina Integral Professor Fernando Figueira
Recife, Pernambuco, 50070-550
About this study
Official title: Effects of Olfactory and Gustatory Stimulus on the Nutrition of Premature Babies: Double-blind Randomized Clinical Trial
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.
Read the 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
- Being tested
- Milk, Water
- Keywords
- Nutrition, Prematurity, human milk, smell and taste
- Medical subject headings
- Birth Weight, Premature Birth, Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MilkOther
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.
WaterOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Milk group | Experimental | Olfactory and gustatory stimuli with milk in premature infants before tube feeding. Receives: Other: Milk |
| Placebo group | Placebo comparator | Olfactory and taste stimuli with double-distilled water in premature infants before tube feeding Receives: Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: until the moment when the newborn's oral or nasal gastric tube will be removed (evaluated up to 1 month).
Secondary outcomes (15)
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.
Measured: until the moment of data collection from the medical records, which is equivalent to 1 day.
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.
Measured: until the moment of data collection from the medical records, which is equivalent to 1 day.
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.
Measured: until the moment of data collection from the medical records, which is equivalent to 1 day.
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.
Measured: until the moment of data collection from the medical records, which is equivalent to 1 day.
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.
Measured: until the moment of data collection from the medical records, which is equivalent to 1 day.
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.
Measured: until the moment of data collection from the medical records, which is equivalent to 1 day.
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.
Measured: until the moment of data collection from the medical records, which is equivalent to 1 day.
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.
Measured: at the time of data collection from the medical record, which is equivalent to 1 day.
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.
Measured: until the moment the tube feeding time will be recorded in days (evaluated up to 2 months).
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.
Measured: until the moment the time of parenteral nutrition feeding will be recorded in days (evaluated up to 15 days).
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.
Measured: until the moment when the type of food offered to the newborn upon discharge will be recorded (evaluated within 2 months).
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.
Measured: until the newborn is 28 days old (assessed until the 28th) and at discharge (up to 2 months)
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.
Measured: until removal of the newborn's tube (assessed up to 2 months) and at discharge (up to 2 months)
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.
Measured: until the moment of discharge of the newborn (evaluated up to 2 months).
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.
Measured: until the moment of discharge of the newborn (assessed up to 2 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start4 Apr 2023
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight, BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Professor Fernando Figueira Integral Medicine Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, João Guilherme Bezerra Alves, Professor Fernando Figueira Integral Medicine Institute
- Investigators
- João GB Alves, PhD, Study director, Instituto de Medicina Integral Fernando Figueira IMIPLuana GR Fonseca, Principal investigator, Instituto de Medicina Integral Fernando Figueira IMIP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06305052
- Sponsor's protocol ID
- estimulation-taste-olfactory
- Other IDs
- 65635922.0.0000.5201
- Status last verified
- Mar 2024
- First submitted
- 9 Feb 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Olfactory and Gustatory Stimulus on the Nutrition of Premature Babies: Double-blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06305052
- Acronym / sponsor ID
- estimulation-taste-olfactory
- Conditions
- Weight, Birth, Premature Birth
- Keywords
- Nutrition, Prematurity, human milk, smell and taste
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Professor Fernando Figueira Integral Medicine InstituteUniversity, hospital or other
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Milk group | Experimental | Other: MilkOlfactory and gustatory stimuli with milk in premature infants before tube feeding. |
| Placebo group | Placebo comparator | Other: WaterOlfactory and taste stimuli with double-distilled water in premature infants before tube feeding |
Who may qualify
- Ages
- 28 to 32 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Newborns with Gestational Age (GA) between 28 and 32 weeks and/or birth weight ≤1,500g.
- Use of oro/nasogastric tube.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MilkPremature 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. | Other | Milk group |
| WaterIn 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. | Other | Placebo group |
Primary outcome
Comparison of the period between the beginning of the intervention and enteral feeding.
Time frame: until the moment when the newborn's oral or nasal gastric tube will be removed (evaluated up to 1 month).
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.
15 secondary outcomes
Describe the gestational age of the newborn
Time frame: until the moment of data collection from the medical records, which is equivalent to 1 day.
Describe the sex of the newborn.
Time frame: until the moment of data collection from the medical records, which is equivalent to 1 day.
Describe the type of birth.
Time frame: until the moment of data collection from the medical records, which is equivalent to 1 day.
Describe the APGAR score.
Time frame: until the moment of data collection from the medical records, which is equivalent to 1 day.
Describe birth weight and birth weight z-score.
Time frame: until the moment of data collection from the medical records, which is equivalent to 1 day.
Describe head circumference at birth and head circumference z-score at birth
Time frame: until the moment of data collection from the medical records, which is equivalent to 1 day.
Describe birth length and birth length z-score.
Time frame: until the moment of data collection from the medical records, which is equivalent to 1 day.
Determine the frequency of rupture of membranes >24h, chorioamnionitis, antepartum hemorrhage, gestational hypertension, pre-eclampsia and prenatal steroids >24h.
Time frame: at the time of data collection from the medical record, which is equivalent to 1 day.
Compare the time, in days, of feeding via oral/nasal gastric tube.
Time frame: until the moment the tube feeding time will be recorded in days (evaluated up to 2 months).
Compare the total duration, in days, of parenteral nutrition (TPN) use.
Time frame: until the moment the time of parenteral nutrition feeding will be recorded in days (evaluated up to 15 days).
Compare the type of food at discharge (natural, artificial or mixed).
Time frame: until the moment when the type of food offered to the newborn upon discharge will be recorded (evaluated within 2 months).
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.
Time frame: until the newborn is 28 days old (assessed until the 28th) and at discharge (up to 2 months)
Compare gestational age (GA) at the time of removal of the oro/nasogastric tube and at discharge from the NICU.
Time frame: until removal of the newborn's tube (assessed up to 2 months) and at discharge (up to 2 months)
Compare the frequency of diagnosis of patent ductus arteriosus requiring treatment, bronchopulmonary dysplasia (BPD), retinopathy of prematurity, intraventricular hemorrhage and necrotizing enterocolitis.
Time frame: until the moment of discharge of the newborn (evaluated up to 2 months).
Determine the association of treatment time with oxygen therapy (nasal catheter, nasal prong - nasal CPAP, intermittent positive pressure or endotracheal ventilation) in hours.
Time frame: until the moment of discharge of the newborn (assessed up to 2 months).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
João GB Alves, PhD study director
Instituto de Medicina Integral Fernando Figueira IMIP
Luana GR Fonseca principal investigator
Instituto de Medicina Integral Fernando Figueira IMIP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milk and Water in people with Weight, Birth and Premature Birth, run by Professor Fernando Figueira Integral Medicine Institute at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the period between the beginning of the intervention and enteral feeding. (time frame: until the moment when the newborn's oral or nasal gastric tube will be removed (evaluated up to 1 month).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.