Oral Colostrum AdministrationNCT06631703
Oropharyngeal Colostrum Administration in Premature Infants
A study testing Group receiving Oral Colostrum Administiration in people with Oral Colostrum Administration and Early Feeding Skills, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
this study aimed to determine the effect of oropharyngeal colostrum administration on premature newborns on early feeding cues and transition time to full oral feeding. Read more about this study
- Who is it for?
- Ages 26 to 33 weeksHealthy volunteers can take part
- Conditions the study is for
- Oral Colostrum Administration, Early Feeding Skills, Transition to Oral Feeding
- What is being tested?
- Group receiving Oral Colostrum Administiration
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 1 Jun 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 26 to 33 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The gestational week at the time of delivery is between 260-33+6 gestational weeks, determined according to the mother's last menstrual date and obstetric evaluation results.
- Started feeding with an orogastric catheter, in the process of transition from catheter feeding to oral feeding
- Meeting early feeding readiness criteria (stable respiration and oxygen saturation during feeding, responsiveness to perioral/oral stimulation and licking, etc.)
- 750 g or more during the study
- Stable vital signs (respiratory rate <60/min, heart rate 140-185 beats/min, axillary temperature 36.5-37.4°C) (Acunaş et al., 2018)
- NICU admission ≤ 24 hours of life; protocol can be started within 72 hours,
- No muscle relaxants, sedatives, or severe neurological disease
- Allowing parents of premature infants
Who cannot join
- Congenital or chromosomal anomalies, lack of cardiorespiratory stabilization, birth asphyxia (cord ph/arterial ph <7. 0), twin or more multiple births, intrauterine growth retardation, necrotizing enterocolitis, pneumothorax, skull fracture, severe atelectasis, circulatory disorder, severe sepsis, having a chest tube, having a history of pathologic jaundice, having a history of antenatal gastrointestinal system disease, born with cleft palate/lip, born to mothers with confirmed chorioamnionitis were excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sümeyra Topal
Kahramanmaraş, Dulkadiroğlu, 46100
About this study
Official title: Effect of Oropharyngeal Colostrum Administration On Early Feeding Skills in Premature Infants
this study aimed to determine the effect of oropharyngeal colostrum administration on premature newborns on early feeding cues and transition time to full oral feeding.
Read the detailed description
Breastfeeding has immunologic, nutritional, and neurodevelopmental benefits for premature infants. Follow-up of premature infants in the Neonatal Intensive Care Unit (NICU) for observation and treatment due to immature gestational age, organ or system diseases, and inadequate oral sucking power cause physical and psychological separation of mother and infant, and this is an essential factor leading to breastfeeding failure. Despite the abundant evidence in the literature for the benefits of breast milk and especially colostrum for premature infants, breastfeeding and lactation rates are still very low in this vulnerable population due to poor sucking/swallowing/respiratory coordination.
Although the development of oral feeding skills in premature infants is a challenge for health professionals and parents, oral feeding skills are one of the critical indicators for the discharge of premature infants. Although motor activities such as sucking, swallowing, and breathing are known to be present in the prenatal period, it is not known precisely when this coordination is achieved at the earliest after birth. Approximately 40% of premature infants have difficulty transitioning from enteral to oral feeding. A systematic review showed that premature infants experience problems with oral feeding in the first four years of life, with a prevalence of 42%. Physiological intervention methods that support the transition of premature infants to oral feeding include non-nutritive sucking, oral-motor stimulation, and oral care with colostrum or breast milk. Oropharyngeal colostrum administration is an intervention method reported to activate the digestive hormones of minimal enteral feeding, encourage feeding, accelerate the maturation of the gastrointestinal system, and shorten the transition to full oral feeding with positive stimulation. When the literature is examined, it is reported that premature infants fed with colostrum from the NICU also have increased breastfeeding continuity after discharge. The most crucial difference between our study and the studies available in the literature is related to how oropharyngeal administered colostrum affects the infant's early feeding cues (coordination of sucking-swallowing and respiration during feeding) and how much it accelerates/shortens the transition to oral feeding. In the literature, no study is similar to our study examining how oropharyngeal colostrum administration affects this process in the transition to full oral feeding using a measurement tool on the subject.
- Being tested
- Group receiving Oral Colostrum Administiration
- Keywords
- Premature infant, oral colostrum, feeding skills
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group receiving Oral Colostrum AdministirationOther
Description: Colostrum secreted in the first 3-5 days was oropharyngeal administered to the intervention group by withdrawing 0.2 ml of colostrum to be taken from the mother with the help of an insulin injector every three hours before each feeding meal in accordance with the literature.In the premature infants in the intervention group in which oropharyngeal colostrum was administered, the application was performed as follows: The oropharyngeal colostrum administration technique consists of slowly inserting a sterile 1 mL syringe without a needle with the tip of the syringe into the baby's mouth along the right buccal mucosa (0.1 mL) towards the oropharynx, then moving the syringe towards the inside of the cheeks and on the tongue, and repeating the same procedure on the left buccal mucosa (0.1 mL) without removing it (slow administration in approximately 1 minute). The routine feeding procedure was then continued
| Study group | Role | What they receive |
|---|---|---|
| Group receiving Oral Colostrum Administiration | Experimental | In the premature infants in the intervention group in which oropharyngeal colostrum was administered, the application was performed as follows: The oropharyngeal colostrum administration technique consists of slowly inserting a sterile 1 mL syringe without a needle with the tip of the syringe into the baby's mouth along the right buccal mucosa (0.1 mL) towards the oropharynx, then moving the syringe towards the inside of the cheeks and on the tongue, and repeating the same procedure on the left buccal mucosa (0.1 mL) without removing it (slow administration in approximately 1 minute). The routine feeding procedure was then continued. Receives: Other: Group receiving Oral Colostrum Administiration |
| Routine Feeding Care | No intervention | According to the NICU guidelines, The control group continued to receive the routine feeding plan. Within the scope of the study, infants in both groups received colostrum, the only difference being the route of administration. The control group received colostrum by gavage, and the study group received colostrum using an oropharyngeal route. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Feeding Skills Assessment
Evaluation will begin with oral colostrum administration to premature infants. The tool allows the assessment of preterm infants' readiness for oral feeding and oral feeding skills, the observation of symptoms associated with problem feeding, and the planning of feeding interventions targeting areas where the infant has difficulty or needs support during the transition to oral feeding. Both the revised EFS and the Turkish version of the EFS include 19 items in 5 subscales. These subscales are respiratory regulation, oral-motor function, swallowing coordination, feeding participation, and physiological stability.
Measured: 10 days
Secondary outcomes (2)
Full oral feeding time
The days of transition to full oral feeding of the babies in the experimental and control groups will be evaluated throughout the application.
Measured: 20 days
Weight gain
The weight gain processes of the babies in the experimental and control groups will be evaluated throughout the application with the scales used in the hospital.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Dec 2023
- Primary completion1 Mar 2024
- Study completion1 Jun 2024
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 Oral Colostrum AdministrationStudies 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
- This single-blind, randomized, controlled study was conducted with a pre-test and post-test control group.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinem Yalnızoglu Caka, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631703
- Sponsor's protocol ID
- 20222503
- Other IDs
- Kocaeli University
- Status last verified
- Oct 2024
- First submitted
- 3 Oct 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nasuf AWA, Ojha S, Dorling J. Oropharyngeal colostrum in preventing mortality and morbidity in preterm infants. Cochrane Database Syst Rev. 2018 Sep 7;9(9):CD011921. doi: 10.1002/14651858.CD011921.pub2.
PubMed 30191961Manerkar S, Kalamdani P, Patra S, Kalathingal T, Mondkar J. Improving Early Colostrum Feeding in a Tertiary Neonatal Intensive Care Unit: A Quality Improvement Initiative. Breastfeed Med. 2022 Feb;17(2):143-148. doi: 10.1089/bfm.2021.0173. Epub 2021 Nov 2.
PubMed 34726511Li L, Liu L, Chen F, Huang L. Clinical effects of oral motor intervention combined with non-nutritive sucking on oral feeding in preterm infants with dysphagia. J Pediatr (Rio J). 2022 Nov-Dec;98(6):635-640. doi: 10.1016/j.jped.2022.02.005. Epub 2022 May 13.
PubMed 35569569Kumar J, Meena J, Ranjan A, Kumar P. Oropharyngeal application of colostrum or mother's own milk in preterm infants: a systematic review and meta-analysis. Nutr Rev. 2023 Sep 11;81(10):1254-1266. doi: 10.1093/nutrit/nuad002.
PubMed 36718589Grundt H, Tandberg BS, Flacking R, Drageset J, Moen A. Associations Between Single-Family Room Care and Breastfeeding Rates in Preterm Infants. J Hum Lact. 2021 Aug;37(3):593-602. doi: 10.1177/0890334420962709. Epub 2020 Oct 9.
PubMed 33035125Glass KM, Greecher CP, Doheny KK. Oropharyngeal Administration of Colostrum Increases Salivary Secretory IgA Levels in Very Low-Birth-Weight Infants. Am J Perinatol. 2017 Dec;34(14):1389-1395. doi: 10.1055/s-0037-1603655. Epub 2017 Jun 2.
PubMed 28575910Zhang Y, Ji F, Hu X, Cao Y, Latour JM. Oropharyngeal Colostrum Administration in Very Low Birth Weight Infants: A Randomized Controlled Trial. Pediatr Crit Care Med. 2017 Sep;18(9):869-875. doi: 10.1097/PCC.0000000000001221.
PubMed 28617764Fu ZY, Huang C, Lei L, Chen LC, Wei LJ, Zhou J, Tao M, Quan MT, Huang Y. The effect of oropharyngeal colostrum administration on the clinical outcomes of premature infants: A meta-analysis. Int J Nurs Stud. 2023 Aug;144:104527. doi: 10.1016/j.ijnurstu.2023.104527. Epub 2023 May 19.
PubMed 37295286da Rosa Pereira K, Levy DS, Procianoy RS, Silveira RC. Impact of a pre-feeding oral stimulation program on first feed attempt in preterm infants: Double-blind controlled clinical trial. PLoS One. 2020 Sep 9;15(9):e0237915. doi: 10.1371/journal.pone.0237915. eCollection 2020.
PubMed 32903261Bashir T, Reddy KV, Kiran S, Murki S, Kulkarni D, Dinesh P. Effect of colostrum given within the 12 hours after birth on feeding outcome, morbidity and mortality in very low birth weight infants: a prospective cohort study. Sudan J Paediatr. 2019;19(1):19-24. doi: 10.24911/SJP.106-1540825552.
PubMed 31384084
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oropharyngeal Colostrum Administration On Early Feeding Skills in Premature Infants
- ClinicalTrials.gov ID
- NCT06631703
- Acronym / sponsor ID
- 20222503
- Keywords
- Premature infant, oral colostrum, feeding skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 8 Oct 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.
this study aimed to determine the effect of oropharyngeal colostrum administration on premature newborns on early feeding cues and transition time to full oral feeding.
Detailed description
Breastfeeding has immunologic, nutritional, and neurodevelopmental benefits for premature infants. Follow-up of premature infants in the Neonatal Intensive Care Unit (NICU) for observation and treatment due to immature gestational age, organ or system diseases, and inadequate oral sucking power cause physical and psychological separation of mother and infant, and this is an essential factor leading to breastfeeding failure. Despite the abundant evidence in the literature for the benefits of breast milk and especially colostrum for premature infants, breastfeeding and lactation rates are still very low in this vulnerable population due to poor sucking/swallowing/respiratory coordination.
Although the development of oral feeding skills in premature infants is a challenge for health professionals and parents, oral feeding skills are one of the critical indicators for the discharge of premature infants. Although motor activities such as sucking, swallowing, and breathing are known to be present in the prenatal period, it is not known precisely when this coordination is achieved at the earliest after birth. Approximately 40% of premature infants have difficulty transitioning from enteral to oral feeding. A systematic review showed that premature infants experience problems with oral feeding in the first four years of life, with a prevalence of 42%. Physiological intervention methods that support the transition of premature infants to oral feeding include non-nutritive sucking, oral-motor stimulation, and oral care with colostrum or breast milk. Oropharyngeal colostrum administration is an intervention method reported to activate the digestive hormones of minimal enteral feeding, encourage feeding, accelerate the maturation of the gastrointestinal system, and shorten the transition to full oral feeding with positive stimulation. When the literature is examined, it is reported that premature infants fed with colostrum from the NICU also have increased breastfeeding continuity after discharge. The most crucial difference between our study and the studies available in the literature is related to how oropharyngeal administered colostrum affects the infant's early feeding cues (coordination of sucking-swallowing and respiration during feeding) and how much it accelerates/shortens the transition to oral feeding. In the literature, no study is similar to our study examining how oropharyngeal colostrum administration affects this process in the transition to full oral feeding using a measurement tool on the subject.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This single-blind, randomized, controlled study was conducted with a pre-test and post-test control group.
| Arm | Type | Receives |
|---|---|---|
| Group receiving Oral Colostrum Administiration | Experimental | Other: Group receiving Oral Colostrum AdministirationIn the premature infants in the intervention group in which oropharyngeal colostrum was administered, the application was performed as follows: The oropharyngeal colostrum administration technique consists of slowly inserting a sterile 1 mL syringe without a needle with the tip of the syringe into the baby's mouth along the right buccal mucosa (0.1 mL) towards the oropharynx, then moving the syringe towards the inside of the cheeks and on the tongue, and repeating the same procedure on the left buccal mucosa (0.1 mL) without removing it (slow administration in approximately 1 minute). The routine feeding procedure was then continued. |
| Routine Feeding Care | No intervention | –According to the NICU guidelines, The control group continued to receive the routine feeding plan. Within the scope of the study, infants in both groups received colostrum, the only difference being the route of administration. The control group received colostrum by gavage, and the study group received colostrum using an oropharyngeal route. |
Who may qualify
- Ages
- 26 to 33 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- The gestational week at the time of delivery is between 260-33+6 gestational weeks, determined according to the mother's last menstrual date and obstetric evaluation results.
- Started feeding with an orogastric catheter, in the process of transition from catheter feeding to oral feeding
- Meeting early feeding readiness criteria (stable respiration and oxygen saturation during feeding, responsiveness to perioral/oral stimulation and licking, etc.)
- 750 g or more during the study
- Stable vital signs (respiratory rate <60/min, heart rate 140-185 beats/min, axillary temperature 36.5-37.4°C) (Acunaş et al., 2018)
Key exclusion criteria (1 listed)
- Congenital or chromosomal anomalies, lack of cardiorespiratory stabilization, birth asphyxia (cord ph/arterial ph <7. 0), twin or more multiple births, intrauterine growth retardation, necrotizing enterocolitis, pneumothorax, skull fracture, severe atelectasis, circulatory disorder, severe sepsis, having a chest tube, having a history of pathologic jaundice, having a history of antenatal gastrointestinal system disease, born with cleft palate/lip, born to mothers with confirmed chorioamnionitis were excluded.
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 |
|---|---|---|
| Group receiving Oral Colostrum AdministirationDescription: Colostrum secreted in the first 3-5 days was oropharyngeal administered to the intervention group by withdrawing 0.2 ml of colostrum to be taken from the mother with the help of an insulin injector every three hours before each feeding meal in accordance with the literature.In the premature infants in the intervention group in which oropharyngeal colostrum was administered, the application was performed as follows: The oropharyngeal colostrum administration technique consists of slowly inserting a sterile 1 mL syringe without a needle with the tip of the syringe into the baby's mouth along the right buccal mucosa (0.1 mL) towards the oropharynx, then moving the syringe towards the inside of the cheeks and on the tongue, and repeating the same procedure on the left buccal mucosa (0.1 mL) without removing it (slow administration in approximately 1 minute). The routine feeding procedure was then continued | Other | Group receiving Oral Colostrum Administiration |
Primary outcome
Early Feeding Skills Assessment
Time frame: 10 days
Evaluation will begin with oral colostrum administration to premature infants. The tool allows the assessment of preterm infants' readiness for oral feeding and oral feeding skills, the observation of symptoms associated with problem feeding, and the planning of feeding interventions targeting areas where the infant has difficulty or needs support during the transition to oral feeding. Both the revised EFS and the Turkish version of the EFS include 19 items in 5 subscales. These subscales are respiratory regulation, oral-motor function, swallowing coordination, feeding participation, and physiological stability.
2 secondary outcomes
Full oral feeding time
Time frame: 20 days
Weight gain
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Results publication: PubMed 30191961Nasuf AWA, Ojha S, Dorling J. Oropharyngeal colostrum in preventing mortality and morbidity in preterm infants. Cochrane Database Syst Rev. 2018 Sep 7;9(9):CD011921. doi: 10.1002/14651858.CD011921.pub2.
- Results publication: PubMed 34726511Manerkar S, Kalamdani P, Patra S, Kalathingal T, Mondkar J. Improving Early Colostrum Feeding in a Tertiary Neonatal Intensive Care Unit: A Quality Improvement Initiative. Breastfeed Med. 2022 Feb;17(2):143-148. doi: 10.1089/bfm.2021.0173. Epub 2021 Nov 2.
- Results publication: PubMed 35569569Li L, Liu L, Chen F, Huang L. Clinical effects of oral motor intervention combined with non-nutritive sucking on oral feeding in preterm infants with dysphagia. J Pediatr (Rio J). 2022 Nov-Dec;98(6):635-640. doi: 10.1016/j.jped.2022.02.005. Epub 2022 May 13.
- Results publication: PubMed 36718589Kumar J, Meena J, Ranjan A, Kumar P. Oropharyngeal application of colostrum or mother's own milk in preterm infants: a systematic review and meta-analysis. Nutr Rev. 2023 Sep 11;81(10):1254-1266. doi: 10.1093/nutrit/nuad002.
- Results publication: PubMed 33035125Grundt H, Tandberg BS, Flacking R, Drageset J, Moen A. Associations Between Single-Family Room Care and Breastfeeding Rates in Preterm Infants. J Hum Lact. 2021 Aug;37(3):593-602. doi: 10.1177/0890334420962709. Epub 2020 Oct 9.
- Results publication: PubMed 28575910Glass KM, Greecher CP, Doheny KK. Oropharyngeal Administration of Colostrum Increases Salivary Secretory IgA Levels in Very Low-Birth-Weight Infants. Am J Perinatol. 2017 Dec;34(14):1389-1395. doi: 10.1055/s-0037-1603655. Epub 2017 Jun 2.
- Results publication: PubMed 28617764Zhang Y, Ji F, Hu X, Cao Y, Latour JM. Oropharyngeal Colostrum Administration in Very Low Birth Weight Infants: A Randomized Controlled Trial. Pediatr Crit Care Med. 2017 Sep;18(9):869-875. doi: 10.1097/PCC.0000000000001221.
- Results publication: PubMed 37295286Fu ZY, Huang C, Lei L, Chen LC, Wei LJ, Zhou J, Tao M, Quan MT, Huang Y. The effect of oropharyngeal colostrum administration on the clinical outcomes of premature infants: A meta-analysis. Int J Nurs Stud. 2023 Aug;144:104527. doi: 10.1016/j.ijnurstu.2023.104527. Epub 2023 May 19.
- Results publication: PubMed 32903261da Rosa Pereira K, Levy DS, Procianoy RS, Silveira RC. Impact of a pre-feeding oral stimulation program on first feed attempt in preterm infants: Double-blind controlled clinical trial. PLoS One. 2020 Sep 9;15(9):e0237915. doi: 10.1371/journal.pone.0237915. eCollection 2020.
- Results publication: PubMed 31384084Bashir T, Reddy KV, Kiran S, Murki S, Kulkarni D, Dinesh P. Effect of colostrum given within the 12 hours after birth on feeding outcome, morbidity and mortality in very low birth weight infants: a prospective cohort study. Sudan J Paediatr. 2019;19(1):19-24. doi: 10.24911/SJP.106-1540825552.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group receiving Oral Colostrum Administiration in people with Oral Colostrum Administration and Early Feeding Skills, run by Kocaeli University 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 1 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: finished, as of the sponsor's last update on 8 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Early Feeding Skills Assessment (time frame: 10 days). 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 NCT06631703, 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 8 Oct 2024.