Breast Feeding, ExclusiveNCT05486663
Tactile/kinesthetic Stimulus Program
A study testing Tactile/kinesthetic Group in people with Breast Feeding, Exclusive and Enteral Feeding, run by Gonca Karatas Baran at 1 site in Turkey (Türkiye).
Trial summary
The study will be carried out as a prospective randomized controlled clinical study to determine the effect of tactile/kinesthetic stimulus program on preterm infants on transition time to full sucking, sucking success and hospital stay. Read more about this study
- Who is it for?
- Ages 28 to 32 weeksHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding, Exclusive, Enteral Feeding, Hospital Stay
- What is being tested?
- Tactile/kinesthetic Group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Born between 28-32 weeks of gestation,
- Stable vital signs,
- 1st and 5th minute APGAR score between 6-10,
- Babies who have received mechanical ventilator or continuous positive air pressure (CPAP) or both support after 48 hours have passed after stabilization,
- Does not have an anomaly that will prevent feeding,
- Oral feeding decision has been made,
- Babies of mothers who are willing to breastfeed their babies,
- Babies of parents who volunteered to participate in the study will be taken.
Who cannot join
- IUGG,
- Infants with severe asphyxia,
- Babies born with low birth weight according to their gestational week,
- Having an anomaly that will prevent her from feeding,
- Babies with unstable vital signs,
- Babies with congenital anomalies or serious complications
Show all 9Show fewer
- Infants with intraventricular bleeding.
- Dismissal Criteria
- Babies whose oral feeding process is interrupted for more than 1 day due to neonatal problems.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Etlık Zubeyde Hanım Kadın Hastalıkları Eğitim Ve Araştırma Hastanesi
Ankara, Eyalet/Yerleşke, 06290
GONCA KARATAS BARAN, PHD, 05426058161, goncabaran@gmail.com
About this study
Official title: The Effect of the Tactile/kinesthetic Stimulus Program on the Maturation of Sucking Ability in Preterm Infants
The study will be carried out as a prospective randomized controlled clinical study to determine the effect of tactile/kinesthetic stimulus program on preterm infants on transition time to full sucking, sucking success and hospital stay.
Read the detailed description
Application of the Research Tactile/kinesthetic Group After the stability in the general health status of the babies and the oral feeding decision are made, for 14 days, 2 times a day, just before feeding; There will be a 15-minute tactile/kinesthetic application. Complications that may develop during the tactile/kinesthetic application in infants will be monitored by evaluating the physical findings of the preterm infant and on the bedside monitor. In cases such as decreased oxygen saturation, apnea and bradycardia during the tactile/kinesthetic intervention, the procedure will not be performed or will be delayed until the baby regains stability.
Note: The application will be carried out by showing the necessary sensitivity for the preterm baby (not shaking the baby, not moving the baby suddenly, the temperature of the hands being close to the baby's body temperature, etc.) and by the researcher nurses experienced in NICU.
Control Group Tactile/kinesthetic applications will not be applied to the control group and these babies will be followed up for 14 days and at discharge after the stability of the general health status of the babies is ensured and the oral feeding decision is made.
In both groups; Baby scales and tape measure will be used for anthropometric measurement of body weight before and after breastfeeding. Other data will be obtained from the patient file and observations made during the hospitalization of the preterm infant.
The LATCH Breastfeeding Diagnosis Form (during the first mother's breastfeeding) will be filled in by observation, by the researcher and an observer nurse, as it is an observation-based form. The researcher will train the observer on the use of the LATCH Breastfeeding Diagnostic Form. The researcher and observer will simultaneously and independently evaluate each preterm infant by scoring the LATCH Breastfeeding Diagnostic Form during the breastfeeding period. In order to evaluate the agreement among the observers, the agreement will be evaluated by looking at Cohen's Kappa coefficient. The LATCH second measurement will be made on Day 5.
The amount of food taken during breastfeeding within 14 days (1st, 5th, 9th, 13th, and on the day of discharge) will be determined by measuring body weight before and after feeding. Body weight will be weighed before and after feeding at discharge. The times of full enteral feeding and full oral feeding will be recorded in the groups.
Hypotheses H0 hypothesis: Tactile/kinesthetic stimulus interventions have no effect on transition time to full oral feeding in preterm infants.
Hypothesis H1: In preterm infants, interventions with tactile/kinesthetic stimuli have an effect on transition time to full oral feeding.
- Conditions
- Breast Feeding, Exclusive, Enteral Feeding, Hospital Stay
- Being tested
- Tactile/kinesthetic Group
- Keywords
- breasfeeding, enteral feeding, tactile/kinesthetic intervention
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tactile/kinesthetic GroupOther
Also called Case
Tactile/kinesthetic stimulation is performed in three stages. In the first stage; for tactile stimulation; The baby is placed in the prone (prone) position in the incubator. Light massage was applied in the head, shoulder, back, legs and arms of the infants. Each massage is applied 12 times for 1 minute. Massage was performed for 5 seconds. In the second stage Kinesthetic stimulation, including elbow flexion-extension movement, palm massages, flexion-extension of the knees and legs and plantar massages, was applied while the neonate was in supine position. Each kinesthetic stimulation was performed for 5 seconds. Each movement was repeated six times, with a total duration of 5 minutes. Tactile stimulation was repeated once after kinesthetic stimulation. The total duration of TKS was 15 minutes which was performed three times daily preferably between breastfeeding or bottle feeding for 14 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Tactile/kinesthetic Group | Experimental | After the stability of the general health status of the babies is ensured and the oral feeding decision is made, tactile / kinesthetic application will be made for 14 days, 2 times a day, for 15 minutes just before feeding. Receives: Other: Tactile/kinesthetic Group |
| Control Group | No intervention | Tactile / kinesthetic applications will not be applied to the control group and these babies will be followed for 14 days and at discharge after the stability of the general health status of the babies is ensured and the oral feeding decision is made. |
What is being measured
The primary outcome is the main question the study is designed to answer.
transition time (day) to full oral feeding
This is the data on which day full oral feeding is started after admission to the neonatal intensive care unit.
Measured: within the first 30 days of birth
transition time(day) to oral feeding trials
This is the data on which day oral feeding trials were performed after admission to the neonatal intensive care unit. intensive care unit.
Measured: within the first 30 days of birth
transition time (day) to full enteral feeding
This is the data on which day full enteral feeding is started after admission to the neonatal intensive care unit.
Measured: within the first 30 days of birth
transition time (day) to enteral feeding trials
This is the data on which day full enteral feeding is started after admission to the neonatal intensive care unit.
Measured: within the first 30 days of birth
time (day) to first breastfeeding
This is the data on which day breastfeeding feeding is started after admission to the neonatal intensive care unit.
Measured: within the first 30 days of birth
latch score (first day of breastfeeding)
Using LATCH Scale. The minimum LATCH score is 0 and the maximum is 10.
Measured: first breastfeeding process (20 minutes)
latch score (fifth day of breastfeeding)
Using LATCH Scale. The minimum LATCH score is 0 and the maximum is 10.
Measured: fifth day breastfeeding process (20 minutes)
length of hospital stay (days)
length of hospital stay (days)
Measured: the date of at discharge (up to 40 weeks)
change in weight before and after feeding
babies will be weighed before and after feeding on the first, fifth, ninth, thirteenth day and at discharge
Measured: the date of at discharge (up to 40 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start1 Aug 2022
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Breast Feeding, ExclusiveStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be two group. One is intervential group, other is control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gonca Karatas Baran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gonca Karatas Baran, Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
- Investigators
- GONCA K KARATAS BARAN, Study director, Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486663
- Sponsor's protocol ID
- NEONATAL CARE
- Status last verified
- Nov 2024
- First submitted
- 29 Jul 2022
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bond C. Positive Touch and massage in the neonatal unit: a British approach. Semin Neonatol. 2002 Dec;7(6):477-86. doi: 10.1053/siny.2002.0149.
PubMed 12614600Burklow KA, McGrath AM, Kaul A. Management and prevention of feeding problems in young children with prematurity and very low birth weight. Inf Young Children. 2002; 14(4):19-30.
Clark GF, Avery-Smith W, Wolf LS, Anthony P, Holm SE, Hertfelder SD, Youngstrom MJ; Eating and Feeding Task Force; Commission on Practice. Specialized knowledge and skills in eating and feeding for occupational therapy practice. Am J Occup Ther. 2003 Nov-Dec;57(6):660-78. doi: 10.5014/ajot.57.6.660. No abstract available.
PubMed 14661785Diego MA, Field T, Hernandez-Reif M. Vagal activity, gastric motility, and weight gain in massaged preterm neonates. J Pediatr. 2005 Jul;147(1):50-5. doi: 10.1016/j.jpeds.2005.02.023.
PubMed 16027695Fucile S, Gisel E, Lau C. Oral stimulation accelerates the transition from tube to oral feeding in preterm infants. J Pediatr. 2002 Aug;141(2):230-6. doi: 10.1067/mpd.2002.125731.
PubMed 12183719Fuccile S. Pre-feeding Sensorimotor Stimulation as an Early Intervention Strategy to Enhance Oral Feeding Skills in Preterm Infants. Health Sciences - Occupational Health and Therapy, doctoral thesis, McGill University, QC, Canada, 2008
Gewolb IH, Vice FL. Abnormalities in the coordination of respiration and swallow in preterm infants with bronchopulmonary dysplasia. Dev Med Child Neurol. 2006 Jul;48(7):595-9. doi: 10.1017/S0012162206001241.
PubMed 16780630Jaywant SS, Kale JS.The effect of pre-feeding protocol with andwithout tactile and kinaesthetic stimulation onoral motor ability & physiological stability inpreterm infants. Int J Health Sci Res. 2021;11(1):38-4
Mathai S, Fernandez A, Mondkar J, Kanbur W. Effects of tactilekinesthetic stimulation in preterms: a controlled trial. Indian Pediatr. 2001; 38(10),:1091-1098. • McGrath JM, Braescu AV. State of the science: feeding readiness in the preterm infant. J Perinat Neonatal Nur. 2004;18(4):353-368
Bache M, Pizon E, Jacobs J, Vaillant M, Lecomte A. Effects of pre-feeding oral stimulation on oral feeding in preterm infants: a randomized clinical trial. Early Hum Dev. 2014 Mar;90(3):125-9. doi: 10.1016/j.earlhumdev.2013.12.011. Epub 2014 Jan 23.
PubMed 24461572
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Tactile/kinesthetic Stimulus Program on the Maturation of Sucking Ability in Preterm Infants
- ClinicalTrials.gov ID
- NCT05486663
- Acronym / sponsor ID
- NEONATAL CARE
- Conditions
- Breast Feeding, Exclusive, Enteral Feeding, Hospital Stay
- Keywords
- breasfeeding, enteral feeding, tactile/kinesthetic intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Gonca Karatas BaranUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 3 Aug 2022 (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 study will be carried out as a prospective randomized controlled clinical study to determine the effect of tactile/kinesthetic stimulus program on preterm infants on transition time to full sucking, sucking success and hospital stay.
Detailed description
Application of the Research Tactile/kinesthetic Group After the stability in the general health status of the babies and the oral feeding decision are made, for 14 days, 2 times a day, just before feeding; There will be a 15-minute tactile/kinesthetic application. Complications that may develop during the tactile/kinesthetic application in infants will be monitored by evaluating the physical findings of the preterm infant and on the bedside monitor. In cases such as decreased oxygen saturation, apnea and bradycardia during the tactile/kinesthetic intervention, the procedure will not be performed or will be delayed until the baby regains stability.
Note: The application will be carried out by showing the necessary sensitivity for the preterm baby (not shaking the baby, not moving the baby suddenly, the temperature of the hands being close to the baby's body temperature, etc.) and by the researcher nurses experienced in NICU.
Control Group Tactile/kinesthetic applications will not be applied to the control group and these babies will be followed up for 14 days and at discharge after the stability of the general health status of the babies is ensured and the oral feeding decision is made.
In both groups; Baby scales and tape measure will be used for anthropometric measurement of body weight before and after breastfeeding. Other data will be obtained from the patient file and observations made during the hospitalization of the preterm infant.
The LATCH Breastfeeding Diagnosis Form (during the first mother's breastfeeding) will be filled in by observation, by the researcher and an observer nurse, as it is an observation-based form. The researcher will train the observer on the use of the LATCH Breastfeeding Diagnostic Form. The researcher and observer will simultaneously and independently evaluate each preterm infant by scoring the LATCH Breastfeeding Diagnostic Form during the breastfeeding period. In order to evaluate the agreement among the observers, the agreement will be evaluated by looking at Cohen's Kappa coefficient. The LATCH second measurement will be made on Day 5.
The amount of food taken during breastfeeding within 14 days (1st, 5th, 9th, 13th, and on the day of discharge) will be determined by measuring body weight before and after feeding. Body weight will be weighed before and after feeding at discharge. The times of full enteral feeding and full oral feeding will be recorded in the groups.
Hypotheses H0 hypothesis: Tactile/kinesthetic stimulus interventions have no effect on transition time to full oral feeding in preterm infants.
Hypothesis H1: In preterm infants, interventions with tactile/kinesthetic stimuli have an effect on transition time to full oral feeding.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- There will be two group. One is intervential group, other is control group
| Arm | Type | Receives |
|---|---|---|
| Tactile/kinesthetic Group | Experimental | Other: Tactile/kinesthetic GroupAfter the stability of the general health status of the babies is ensured and the oral feeding decision is made, tactile / kinesthetic application will be made for 14 days, 2 times a day, for 15 minutes just before feeding. |
| Control Group | No intervention | –Tactile / kinesthetic applications will not be applied to the control group and these babies will be followed for 14 days and at discharge after the stability of the general health status of the babies is ensured and the oral feeding decision is made. |
Who may qualify
- Ages
- 28 to 32 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Born between 28-32 weeks of gestation,
- Stable vital signs,
- 1st and 5th minute APGAR score between 6-10,
- Babies who have received mechanical ventilator or continuous positive air pressure (CPAP) or both support after 48 hours have passed after stabilization,
- Does not have an anomaly that will prevent feeding,
Key exclusion criteria (9 listed)
- IUGG,
- Infants with severe asphyxia,
- Babies born with low birth weight according to their gestational week,
- Having an anomaly that will prevent her from feeding,
- Babies with unstable vital signs,
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 |
|---|---|---|
| Tactile/kinesthetic GroupAlso: CaseTactile/kinesthetic stimulation is performed in three stages. In the first stage; for tactile stimulation; The baby is placed in the prone (prone) position in the incubator. Light massage was applied in the head, shoulder, back, legs and arms of the infants. Each massage is applied 12 times for 1 minute. Massage was performed for 5 seconds. In the second stage Kinesthetic stimulation, including elbow flexion-extension movement, palm massages, flexion-extension of the knees and legs and plantar massages, was applied while the neonate was in supine position. Each kinesthetic stimulation was performed for 5 seconds. Each movement was repeated six times, with a total duration of 5 minutes. Tactile stimulation was repeated once after kinesthetic stimulation. The total duration of TKS was 15 minutes which was performed three times daily preferably between breastfeeding or bottle feeding for 14 consecutive days. | Other | Tactile/kinesthetic Group |
Primary outcome
transition time (day) to full oral feeding
Time frame: within the first 30 days of birth
This is the data on which day full oral feeding is started after admission to the neonatal intensive care unit.
transition time(day) to oral feeding trials
Time frame: within the first 30 days of birth
This is the data on which day oral feeding trials were performed after admission to the neonatal intensive care unit. intensive care unit.
transition time (day) to full enteral feeding
Time frame: within the first 30 days of birth
This is the data on which day full enteral feeding is started after admission to the neonatal intensive care unit.
transition time (day) to enteral feeding trials
Time frame: within the first 30 days of birth
This is the data on which day full enteral feeding is started after admission to the neonatal intensive care unit.
time (day) to first breastfeeding
Time frame: within the first 30 days of birth
This is the data on which day breastfeeding feeding is started after admission to the neonatal intensive care unit.
latch score (first day of breastfeeding)
Time frame: first breastfeeding process (20 minutes)
Using LATCH Scale. The minimum LATCH score is 0 and the maximum is 10.
latch score (fifth day of breastfeeding)
Time frame: fifth day breastfeeding process (20 minutes)
Using LATCH Scale. The minimum LATCH score is 0 and the maximum is 10.
length of hospital stay (days)
Time frame: the date of at discharge (up to 40 weeks)
length of hospital stay (days)
change in weight before and after feeding
Time frame: the date of at discharge (up to 40 weeks)
babies will be weighed before and after feeding on the first, fifth, ninth, thirteenth day and at discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Background: PubMed 12614600Bond C. Positive Touch and massage in the neonatal unit: a British approach. Semin Neonatol. 2002 Dec;7(6):477-86. doi: 10.1053/siny.2002.0149.
- BackgroundBurklow KA, McGrath AM, Kaul A. Management and prevention of feeding problems in young children with prematurity and very low birth weight. Inf Young Children. 2002; 14(4):19-30.
- Background: PubMed 14661785Clark GF, Avery-Smith W, Wolf LS, Anthony P, Holm SE, Hertfelder SD, Youngstrom MJ; Eating and Feeding Task Force; Commission on Practice. Specialized knowledge and skills in eating and feeding for occupational therapy practice. Am J Occup Ther. 2003 Nov-Dec;57(6):660-78. doi: 10.5014/ajot.57.6.660. No abstract available.
- Background: PubMed 16027695Diego MA, Field T, Hernandez-Reif M. Vagal activity, gastric motility, and weight gain in massaged preterm neonates. J Pediatr. 2005 Jul;147(1):50-5. doi: 10.1016/j.jpeds.2005.02.023.
- Background: PubMed 12183719Fucile S, Gisel E, Lau C. Oral stimulation accelerates the transition from tube to oral feeding in preterm infants. J Pediatr. 2002 Aug;141(2):230-6. doi: 10.1067/mpd.2002.125731.
- BackgroundFuccile S. Pre-feeding Sensorimotor Stimulation as an Early Intervention Strategy to Enhance Oral Feeding Skills in Preterm Infants. Health Sciences - Occupational Health and Therapy, doctoral thesis, McGill University, QC, Canada, 2008
- Background: PubMed 16780630Gewolb IH, Vice FL. Abnormalities in the coordination of respiration and swallow in preterm infants with bronchopulmonary dysplasia. Dev Med Child Neurol. 2006 Jul;48(7):595-9. doi: 10.1017/S0012162206001241.
- BackgroundJaywant SS, Kale JS.The effect of pre-feeding protocol with andwithout tactile and kinaesthetic stimulation onoral motor ability & physiological stability inpreterm infants. Int J Health Sci Res. 2021;11(1):38-4
- BackgroundMathai S, Fernandez A, Mondkar J, Kanbur W. Effects of tactilekinesthetic stimulation in preterms: a controlled trial. Indian Pediatr. 2001; 38(10),:1091-1098. • McGrath JM, Braescu AV. State of the science: feeding readiness in the preterm infant. J Perinat Neonatal Nur. 2004;18(4):353-368
- Background: PubMed 24461572Bache M, Pizon E, Jacobs J, Vaillant M, Lecomte A. Effects of pre-feeding oral stimulation on oral feeding in preterm infants: a randomized clinical trial. Early Hum Dev. 2014 Mar;90(3):125-9. doi: 10.1016/j.earlhumdev.2013.12.011. Epub 2014 Jan 23.
- Individual participant dataSharing planned: No
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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.
GONCA K KARATAS BARAN study director
Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tactile/kinesthetic Group in people with Breast Feeding, Exclusive and Enteral Feeding, run by Gonca Karatas Baran at 1 site in Turkey (Türkiye).
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 8 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 22 Nov 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 Turkey (Türkiye). 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact GONCA K KARATAS BARAN, PHD (05426058161, goncabaran@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
transition time (day) to full oral feeding (time frame: within the first 30 days of birth). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05486663, which also lists 10 linked publications.
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 22 Nov 2024.