Parents of Premature InfantsNCT06987227
Effects of Intelligent Parent-child Bonding Intervention on the Physical, Psychological and Social Health of Parents of Premature Infants During Hospitalization and Return Home
A study testing Intelligent intervention to enhance parent-child connection and Routine care in people with Parents of Premature Infants and Intelligent Intervention, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
Trial summary
The study purpose is to construct and validate the effects of "intelligent parent-child bonding intervention" on the physical, psychological and social health of parents of premature infants. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parents of Premature Infants, Intelligent Intervention, Parent-child Connection
- What is being tested?
- Intelligent intervention to enhance parent-child connection and Routine care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 May 2025to 31 Mar 2028
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: 1. Parents of premature infants born less than 37 weeks of age; 2. Parents of premature infants aged 20 or above and able to communicate in Mandarin and Taiwanese; 3. Parents of premature infants agree to participate in this study and sign the research consent form; 4. The child is currently in the Pediatric and Neonatal Intensive Care Center
Exclusion Criteria: 1. The premature baby has congenital abnormalities or is in critical condition and cannot survive; 2. The parents cannot use mobile phones or other Internet devices; 3. The parents have a history of mental illness, intellectual disability or substance abuse.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Hsiang-Yun Lan
Teipei, Taiwan
Hsiang-Yun Dr. Lan, Doctoral, +886-919338200, shinnylan@gmail.com
About this study
Official title: Effects of a Smart Parent-child Bonding Intervention on the Physical, Psychological, and Social Health of Parents of Preterm Infants During Hospitalization and Home Return: a Randomized Controlled Trial
The study purpose is to construct and validate the effects of "intelligent parent-child bonding intervention" on the physical, psychological and social health of parents of premature infants.
Read the detailed description
Background:
Premature babies are born at 20 weeks but less than 37 weeks of gestation. In 2020, there were approximately 13.4 million premature babies worldwide, accounting for 10% of the total number of newborns. Although Taiwan's birth rate has declined, the premature birth rate has increased year by year due to factors such as late marriage and childbirth at an advanced age, reaching 10.88% in 2023. Premature birth survivors face long-term physical and psychological challenges that affect their quality of life and cause significant stress for their families, including anxiety and depression. Mother-child separation is considered "toxic stress" that affects parent-child relationships and family function. Therefore, establishing a bond with your newborn is critical to the health of both the parents and the premature infant.
Methods:
This study was a three-year randomized controlled trial using a longitudinal repeated measures design. Convenience sampling will be used to recruit 360 parents of premature infants in the pediatric and neonatal intensive care unit of a northern medical center. Participants will be randomly assigned to two conditions (usual care and smart parent-child bonding intervention). The intervention will begin during the premature infant's hospital stay until the first month after discharge. Data will be collected using questionnaires and biometrics. Outcome variables included sleep status, fatigue, stress, anxiety, depression, self-efficacy, parent-child connection, partner relationship, family resilience, and quality of life of parents of preterm infants. In addition, these data will be collected before the intervention, 2 weeks after the intervention, before premature infants are discharged from the hospital, and in the first month after premature infants return home. It is expected that the generalized estimating equation method will be used to analyze the research results.
- Being tested
- Intelligent intervention to enhance parent-child connection, Routine care
- Keywords
- physical health, psychological health, parents of premature infants, social health, Intelligent intervention, parent-child connection
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intelligent intervention to enhance parent-child connectionBehavioural
The "Intelligent Intervention to Enhance Parent-Child Connection" support program is mainly carried out through web pages, Figma software, cloud files and official Line accounts. It can be divided into: the first stage is to provide parents with care knowledge and skills during the hospitalization of premature infants, provide parents with physical and mental support, and encourage parents to establish parent-child connections and prepare for discharge. The second stage is after discharge, continuing to provide premature infants' families with the care guidance needed to respond to the different stages of development of premature infants, including interpersonal support, sleep schedule establishment, crying comfort, premature infant nutrition and couple relationship management, etc., and continue to provide family support, answer questions and track its implementation status.
Routine careOther
Premature infants receive routine care during their hospitalization, and general nursing guidance for premature infant discharge care is provided before discharge.
| Study group | Role | What they receive |
|---|---|---|
| Intelligent intervention to enhance parent-child connection | Experimental | In addition to routine care, premature infants will receive "intelligent parent-child connection intervention" during hospitalization and continue to use it until one month after the premature infant returns home. Receives: Behavioral: Intelligent intervention to enhance parent-child connection; Other: Routine care |
| Routine care group | Active comparator | Routine care is provided to premature infants during hospitalization, and general nursing guidance for premature infant discharge care is provided before discharge. Receives: Other: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Pittsburgh Sleep Quality Index, PSQI
The sleep quality in the past month was measured, including seven indicators: subjective statement of sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, use of sleep aids and daytime dysfunction. Each indicator was scored between 0-3 points, and the total score ranged from 0-21 points. The higher the score, the worse the sleep quality. When the total score of sleep quality is >5 points, it means poor sleep quality, and the total score of sleep quality is ≤5 points, it means good sleep quality.
Measured: Changes in parents' sleep patterns before premature infants are discharged from hospital and in the first month after premature infants return home
Actigraphy and Sleep Diary measures sleep details
The Cole-Kripke algorithm was used to calculate the following data: (1) total sleep time: the actual time of falling asleep; (2) sleep efficiency: the percentage of time in bed compared to the actual sleep time; (3) sleep latency: the time from the time in bed to the time of falling asleep recorded by the actigraph; and (4) number of awakenings: the number of awakenings during a sleep cycle. The sleep log is recalled by the primary caregiver immediately after waking up every day, recording the sleep time and sleep status of the previous day, in order to understand the total sleep hours, the number of awakening hours/times at night, sleep efficiency, and whether there are any events that affect the mood for falling asleep, medication or physical discomfort, whether stimulants and alcohol are consumed, etc., and the sleep quality of the previous night and the degree of wakefulness when waking up are evaluated on a scale of 1 to 5 points.
Measured: Changes in parents' sleep details before premature infants are discharged from hospital and in the first month after premature infants return home
Brief Fatigue Inventory, BFI
The scale is divided into two parts: the severity of fatigue and the degree of interference of fatigue on life. There are 9 questions in total, each with a score of 0 to 10 points. The total score is calculated as the average score of the first part plus the average score of the second part. The higher the score, the higher the degree of fatigue.
Measured: Changes in parental fatigue before premature infants were discharged from hospital and in the first month after they returned home
Perceived Stress Scale, PSS
This scale is used to measure the stress level in an individual's life. The original scale has 14 questions, using the Likert scoring method, with a scoring method ranging from 0 (never), 1 (occasionally), 2 (sometimes), 3 (often) to 4 (always). Questions 4, 5, 6, 7, 9, 10, and 13 are reverse scored. The total score ranges from 0 to 56. The higher the score, the higher the stress level of the subject.
Measured: Changes in parental perceived stress before premature infants were discharged from hospital and in the first month after they returned home
Postpartum Specific Anxiety Scale
The frequency scale used to assess the anxiety focused on mothers and infants experienced by women in the past week has a total of 12 questions, which are classified into four sub-items according to the content: maternal ability and attachment anxiety, infant safety and health anxiety, infant care anxiety, and maternal psychosocial adaptation. The Likert four-point scoring method is used, with each question ranging from 1 to 4 points, from low to high representing "never", "rarely", "often", and "always". The total score ranges from 12 to 48 points, and the higher the score, the higher the level of anxiety.
Measured: Changes in parental anxiety before premature infants were discharged from hospital and in the first month after they returned home
Edinburgh Postpartum Depression Scale
There are 10 questions in total. Each item is scored from 0 to 3 points, and the total score range is 0 to 30 points. The higher the score, the more severe the depression symptoms. It is recommended that scores of ≧10 and ≧9 be used as the criteria for screening postpartum depression symptoms for fathers and mothers respectively.
Measured: Changes in parental depression before premature infants were discharged from hospital and in the first month after they returned home
Parental Self-efficacy scale, PSE Scale
It is divided into three aspects: (1) Parenting role evaluation: refers to the overall feeling of one's own parenting effectiveness; (2) Parenting confidence: refers to the feeling of whether one has the confidence and competence to do the work of raising children; (3) Parenting ability: refers to the recognition and understanding of one's own ability to actually carry out the work of raising children. The scale has 20 questions, which are scored on a Likert scale, with a total score of 20-100 points. The higher the score, the higher the evaluation of one's own parenting ability. There are seven questions about parenting confidence, all of which are reverse questions.
Measured: Changes in parental self-efficacy before premature infants were discharged from hospital and in the first month after they returned home
Parent-infant bonding
The scale questions adopt the Likert six-point scoring method, with each question scoring from 1 to 6 points, and the options range from "strongly disagree" to "strongly agree". Among them, only the "parenting adaptation" item adopts the reverse scoring method. The higher the score, the better the mother-infant connection in this dimension.
Measured: Changes in parent-infant bonding before premature infants were discharged from hospital and in the first month after they returned home
Relationship Assessment Scale, RAS
The scale consists of 7 questions, using the Likert five-point scoring method. Each question has a score of 1 to 5. The number 1 indicates the lowest score (such as "very poor" or "unsatisfied"), and the number 5 indicates the highest score (such as "very good" or "completely satisfied"). Please answer according to your own feelings. The total score ranges from 7 to 35 points. The higher the score, the more satisfied the individual is with the relationship between husband and wife/partner.
Measured: Changes in parental relationship before premature infants were discharged from hospital and in the first month after they returned home
Family Resilience Assessment
This scale has a total of 31 questions, covering three categories, namely belief system (a total of 13 questions), organizational model (a total of 9 questions) and family communication process (a total of 9 questions). It adopts Likert's five-point scoring method, "strongly agree" (5 points) and "strongly disagree" (1 point). The higher the score, the better the family resilience.
Measured: Changes in family resilience before premature infants were discharged from hospital and in the first month after they returned home
World Health Organization Quality of Life-BREF, WHOQOL-BREF
There are 28 questions in total, with the past two weeks as the reference point, to assess the quality of life. The content includes four aspects: physical health, psychology, social relations and environment. The Likert five-point scoring method is adopted. The higher the score, the better the quality of life.
Measured: Changes in quality of life before premature infants were discharged from hospital and in the first month after they returned home
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start25 May 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parents of Premature InfantsStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsiang-Yun Lan, National Defense Medical Center, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987227
- Sponsor's protocol ID
- B2025050055
- Status last verified
- May 2026
- First submitted
- 18 Apr 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Smart Parent-child Bonding Intervention on the Physical, Psychological, and Social Health of Parents of Preterm Infants During Hospitalization and Home Return: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06987227
- Acronym / sponsor ID
- B2025050055
- Keywords
- physical health, psychological health, parents of premature infants, social health, Intelligent intervention, parent-child connection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Study start
- 25 May 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 23 May 2025 (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 purpose is to construct and validate the effects of "intelligent parent-child bonding intervention" on the physical, psychological and social health of parents of premature infants.
Detailed description
Background:
Premature babies are born at 20 weeks but less than 37 weeks of gestation. In 2020, there were approximately 13.4 million premature babies worldwide, accounting for 10% of the total number of newborns. Although Taiwan's birth rate has declined, the premature birth rate has increased year by year due to factors such as late marriage and childbirth at an advanced age, reaching 10.88% in 2023. Premature birth survivors face long-term physical and psychological challenges that affect their quality of life and cause significant stress for their families, including anxiety and depression. Mother-child separation is considered "toxic stress" that affects parent-child relationships and family function. Therefore, establishing a bond with your newborn is critical to the health of both the parents and the premature infant.
Methods:
This study was a three-year randomized controlled trial using a longitudinal repeated measures design. Convenience sampling will be used to recruit 360 parents of premature infants in the pediatric and neonatal intensive care unit of a northern medical center. Participants will be randomly assigned to two conditions (usual care and smart parent-child bonding intervention). The intervention will begin during the premature infant's hospital stay until the first month after discharge. Data will be collected using questionnaires and biometrics. Outcome variables included sleep status, fatigue, stress, anxiety, depression, self-efficacy, parent-child connection, partner relationship, family resilience, and quality of life of parents of preterm infants. In addition, these data will be collected before the intervention, 2 weeks after the intervention, before premature infants are discharged from the hospital, and in the first month after premature infants return home. It is expected that the generalized estimating equation method will be used to analyze the research results.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intelligent intervention to enhance parent-child connection | Experimental | Behavioral: Intelligent intervention to enhance parent-child connection, Other: Routine careIn addition to routine care, premature infants will receive "intelligent parent-child connection intervention" during hospitalization and continue to use it until one month after the premature infant returns home. |
| Routine care group | Active comparator | Other: Routine careRoutine care is provided to premature infants during hospitalization, and general nursing guidance for premature infant discharge care is provided before discharge. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Intelligent intervention to enhance parent-child connectionThe "Intelligent Intervention to Enhance Parent-Child Connection" support program is mainly carried out through web pages, Figma software, cloud files and official Line accounts. It can be divided into: the first stage is to provide parents with care knowledge and skills during the hospitalization of premature infants, provide parents with physical and mental support, and encourage parents to establish parent-child connections and prepare for discharge. The second stage is after discharge, continuing to provide premature infants' families with the care guidance needed to respond to the different stages of development of premature infants, including interpersonal support, sleep schedule establishment, crying comfort, premature infant nutrition and couple relationship management, etc., and continue to provide family support, answer questions and track its implementation status. | Behavioural | Intelligent intervention to enhance parent-child connection |
| Routine carePremature infants receive routine care during their hospitalization, and general nursing guidance for premature infant discharge care is provided before discharge. | Other | Intelligent intervention to enhance parent-child connection, Routine care group |
Primary outcome
The Pittsburgh Sleep Quality Index, PSQI
Time frame: Changes in parents' sleep patterns before premature infants are discharged from hospital and in the first month after premature infants return home
The sleep quality in the past month was measured, including seven indicators: subjective statement of sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, use of sleep aids and daytime dysfunction. Each indicator was scored between 0-3 points, and the total score ranged from 0-21 points. The higher the score, the worse the sleep quality. When the total score of sleep quality is >5 points, it means poor sleep quality, and the total score of sleep quality is ≤5 points, it means good sleep quality.
Actigraphy and Sleep Diary measures sleep details
Time frame: Changes in parents' sleep details before premature infants are discharged from hospital and in the first month after premature infants return home
The Cole-Kripke algorithm was used to calculate the following data: (1) total sleep time: the actual time of falling asleep; (2) sleep efficiency: the percentage of time in bed compared to the actual sleep time; (3) sleep latency: the time from the time in bed to the time of falling asleep recorded by the actigraph; and (4) number of awakenings: the number of awakenings during a sleep cycle. The sleep log is recalled by the primary caregiver immediately after waking up every day, recording the sleep time and sleep status of the previous day, in order to understand the total sleep hours, the number of awakening hours/times at night, sleep efficiency, and whether there are any events that affect the mood for falling asleep, medication or physical discomfort, whether stimulants and alcohol are consumed, etc., and the sleep quality of the previous night and the degree of wakefulness when waking up are evaluated on a scale of 1 to 5 points.
Brief Fatigue Inventory, BFI
Time frame: Changes in parental fatigue before premature infants were discharged from hospital and in the first month after they returned home
The scale is divided into two parts: the severity of fatigue and the degree of interference of fatigue on life. There are 9 questions in total, each with a score of 0 to 10 points. The total score is calculated as the average score of the first part plus the average score of the second part. The higher the score, the higher the degree of fatigue.
Perceived Stress Scale, PSS
Time frame: Changes in parental perceived stress before premature infants were discharged from hospital and in the first month after they returned home
This scale is used to measure the stress level in an individual's life. The original scale has 14 questions, using the Likert scoring method, with a scoring method ranging from 0 (never), 1 (occasionally), 2 (sometimes), 3 (often) to 4 (always). Questions 4, 5, 6, 7, 9, 10, and 13 are reverse scored. The total score ranges from 0 to 56. The higher the score, the higher the stress level of the subject.
Postpartum Specific Anxiety Scale
Time frame: Changes in parental anxiety before premature infants were discharged from hospital and in the first month after they returned home
The frequency scale used to assess the anxiety focused on mothers and infants experienced by women in the past week has a total of 12 questions, which are classified into four sub-items according to the content: maternal ability and attachment anxiety, infant safety and health anxiety, infant care anxiety, and maternal psychosocial adaptation. The Likert four-point scoring method is used, with each question ranging from 1 to 4 points, from low to high representing "never", "rarely", "often", and "always". The total score ranges from 12 to 48 points, and the higher the score, the higher the level of anxiety.
Edinburgh Postpartum Depression Scale
Time frame: Changes in parental depression before premature infants were discharged from hospital and in the first month after they returned home
There are 10 questions in total. Each item is scored from 0 to 3 points, and the total score range is 0 to 30 points. The higher the score, the more severe the depression symptoms. It is recommended that scores of ≧10 and ≧9 be used as the criteria for screening postpartum depression symptoms for fathers and mothers respectively.
Parental Self-efficacy scale, PSE Scale
Time frame: Changes in parental self-efficacy before premature infants were discharged from hospital and in the first month after they returned home
It is divided into three aspects: (1) Parenting role evaluation: refers to the overall feeling of one's own parenting effectiveness; (2) Parenting confidence: refers to the feeling of whether one has the confidence and competence to do the work of raising children; (3) Parenting ability: refers to the recognition and understanding of one's own ability to actually carry out the work of raising children. The scale has 20 questions, which are scored on a Likert scale, with a total score of 20-100 points. The higher the score, the higher the evaluation of one's own parenting ability. There are seven questions about parenting confidence, all of which are reverse questions.
Parent-infant bonding
Time frame: Changes in parent-infant bonding before premature infants were discharged from hospital and in the first month after they returned home
The scale questions adopt the Likert six-point scoring method, with each question scoring from 1 to 6 points, and the options range from "strongly disagree" to "strongly agree". Among them, only the "parenting adaptation" item adopts the reverse scoring method. The higher the score, the better the mother-infant connection in this dimension.
Relationship Assessment Scale, RAS
Time frame: Changes in parental relationship before premature infants were discharged from hospital and in the first month after they returned home
The scale consists of 7 questions, using the Likert five-point scoring method. Each question has a score of 1 to 5. The number 1 indicates the lowest score (such as "very poor" or "unsatisfied"), and the number 5 indicates the highest score (such as "very good" or "completely satisfied"). Please answer according to your own feelings. The total score ranges from 7 to 35 points. The higher the score, the more satisfied the individual is with the relationship between husband and wife/partner.
Family Resilience Assessment
Time frame: Changes in family resilience before premature infants were discharged from hospital and in the first month after they returned home
This scale has a total of 31 questions, covering three categories, namely belief system (a total of 13 questions), organizational model (a total of 9 questions) and family communication process (a total of 9 questions). It adopts Likert's five-point scoring method, "strongly agree" (5 points) and "strongly disagree" (1 point). The higher the score, the better the family resilience.
World Health Organization Quality of Life-BREF, WHOQOL-BREF
Time frame: Changes in quality of life before premature infants were discharged from hospital and in the first month after they returned home
There are 28 questions in total, with the past two weeks as the reference point, to assess the quality of life. The content includes four aspects: physical health, psychology, social relations and environment. The Likert five-point scoring method is adopted. The higher the score, the better the quality of life.
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 7 May 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intelligent intervention to enhance parent-child connection and Routine care in people with Parents of Premature Infants and Intelligent Intervention, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 7 May 2026. 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 Taiwan. 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 Lan Hsiang-Yun, A.P. (+886287923100 Ext. 18781, shinnylan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Pittsburgh Sleep Quality Index, PSQI (time frame: Changes in parents' sleep patterns before premature infants are discharged from hospital and in the first month after premature infants return home). The study lists 11 primary outcomes in all. 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 7 May 2026.