Infantile HaemangiomasNCT04651049
Systemic Propranolol for the Treatment of Paediatric Patients With Infantile Hemangiomas
An observational study of Infantile Haemangiomas, run by Qilu Hospital of Shandong University.
Trial summary
This is retrospective study. The patients treated with oral propranolol at a dose of 2.0 mg/kg per day. Growth parameters (height and weight) were measured at the beginning, the end of treatment and 2 years after treatment. Read more about this study
- Who is it for?
- Ages 2 to 54 weeks
- Conditions the study is for
- Infantile Haemangiomas
- What is being tested?
- propranolol
- Type of treatment
- Pill or oral medicine
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2010to 10 Feb 2020
- Phase
- Observational
- 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 2 to 54 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Overall, 52 males and 76 females, with a male-to-female ratio of 1:1.46, were included in this study. Of the 128 patients, 16 (12.5%) were born prematurely. The median age at the start of propranolol therapy was 3.75 months (0.5-12.5 months). Propranolol was administered for a median duration of 10.52 months (2-24 months).
Who may be able to join
- IHs diagnosed by medical history and physical examination
- no previous treatment with other medications
Who cannot join
- a history or risk of asthma, reactive airway disease, impaired renal or liver function, heart defects or arrhythmia, hypotension and hypersensitivity to propranolol
- Infants who did not adhere to the treatments or attend follow-up visits
- Infants with other known risk factors for developmental delay or growth restriction, such as prematurity, small for gestational age, or other major congenital malformations, were also excluded
- No other treatment was used during the oral propranolol course
About this study
Official title: Influence of Systemic Propranolol Treatment on the Physical Development of Paediatric Patients With Infantile Hemangiomas
This is retrospective study. The patients treated with oral propranolol at a dose of 2.0 mg/kg per day. Growth parameters (height and weight) were measured at the beginning, the end of treatment and 2 years after treatment. The weight-for-age Z-score (WAZ), height-for-age Z-score (HAZ) and weight-for-height Z-score (WHZ) calculated by the WHO Anthro software were used to assess physical development, and the WHO Child Growth Standards were used as the standards.
- Conditions
- Infantile Haemangiomas
- Being tested
- propranolol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propranololDrug
This retrospective study included 128 patients treated with oral propranolol at a dose of 2.0 mg/kg per day.
Device
| Study group | Role | What they receive |
|---|---|---|
| Propranolol treatment group | Not described Receives: Drug: propranolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on the height of the patients
we recorded the height of the patients in meters.
Measured: at the beginning of the treatment, at the end of treatment and 2 years after the treatment
Change on the weight of the patients
we recorded the weight of the patients in kilograms.
Measured: at the beginning of the treatment, at the end of treatment and 2 years after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start15 Jul 2010
- Primary completion15 Dec 2017
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infantile HaemangiomasStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shaohua Liu, Dr., Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651049
- Sponsor's protocol ID
- LiuSH
- Status last verified
- Aug 2020
- First submitted
- 18 Nov 2020
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Chen ZY, Wang QN, Zhu YH, Zhou LY, Xu T, He ZY, Yang Y. Progress in the treatment of infantile hemangioma. Ann Transl Med. 2019 Nov;7(22):692. doi: 10.21037/atm.2019.10.47.
PubMed 31930093Hoeger PH, Harper JI, Baselga E, Bonnet D, Boon LM, Ciofi Degli Atti M, El Hachem M, Oranje AP, Rubin AT, Weibel L, Leaute-Labreze C. Treatment of infantile haemangiomas: recommendations of a European expert group. Eur J Pediatr. 2015 Jul;174(7):855-65. doi: 10.1007/s00431-015-2570-0. Epub 2015 May 29.
PubMed 26021855
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Systemic Propranolol Treatment on the Physical Development of Paediatric Patients With Infantile Hemangiomas
- ClinicalTrials.gov ID
- NCT04651049
- Acronym / sponsor ID
- LiuSH
- Conditions
- Infantile Haemangiomas
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 15 Jul 2010 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 3 Dec 2020 (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 is retrospective study. The patients treated with oral propranolol at a dose of 2.0 mg/kg per day. Growth parameters (height and weight) were measured at the beginning, the end of treatment and 2 years after treatment. The weight-for-age Z-score (WAZ), height-for-age Z-score (HAZ) and weight-for-height Z-score (WHZ) calculated by the WHO Anthro software were used to assess physical development, and the WHO Child Growth Standards were used as the standards.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Propranolol treatment group | – | Drug: propranolol |
Who may qualify
- Ages
- 2 to 54 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Overall, 52 males and 76 females, with a male-to-female ratio of 1:1.46, were included in this study. Of the 128 patients, 16 (12.5%) were born prematurely. The median age at the start of propranolol therapy was 3.75 months (0.5-12.5 months). Propranolol was administered for a median duration of 10.52 months (2-24 months).
Key inclusion criteria (2 listed)
- IHs diagnosed by medical history and physical examination
- no previous treatment with other medications
Key exclusion criteria (4 listed)
- a history or risk of asthma, reactive airway disease, impaired renal or liver function, heart defects or arrhythmia, hypotension and hypersensitivity to propranolol
- Infants who did not adhere to the treatments or attend follow-up visits
- Infants with other known risk factors for developmental delay or growth restriction, such as prematurity, small for gestational age, or other major congenital malformations, were also excluded
- No other treatment was used during the oral propranolol course
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 |
|---|---|---|
| propranololThis retrospective study included 128 patients treated with oral propranolol at a dose of 2.0 mg/kg per day. | Drug | Propranolol treatment group |
| Device | Propranolol treatment group |
Primary outcome
Change on the height of the patients
Time frame: at the beginning of the treatment, at the end of treatment and 2 years after the treatment
we recorded the height of the patients in meters.
Change on the weight of the patients
Time frame: at the beginning of the treatment, at the end of treatment and 2 years after the treatment
we recorded the weight of the patients in kilograms.
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 3 Dec 2020.
- Background: PubMed 31930093Chen ZY, Wang QN, Zhu YH, Zhou LY, Xu T, He ZY, Yang Y. Progress in the treatment of infantile hemangioma. Ann Transl Med. 2019 Nov;7(22):692. doi: 10.21037/atm.2019.10.47.
- Results publication: PubMed 26021855Hoeger PH, Harper JI, Baselga E, Bonnet D, Boon LM, Ciofi Degli Atti M, El Hachem M, Oranje AP, Rubin AT, Weibel L, Leaute-Labreze C. Treatment of infantile haemangiomas: recommendations of a European expert group. Eur J Pediatr. 2015 Jul;174(7):855-65. doi: 10.1007/s00431-015-2570-0. Epub 2015 May 29.
- Individual participant dataSharing planned: Undecided
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.
Shaohua Liu, Dr. principal investigator
Qilu Hospital of Shandong University
Questions about this trial
What is this clinical trial studying?
An observational study of Infantile Haemangiomas, run by Qilu Hospital of Shandong University.
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: finished, as of the sponsor's last update on 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Change on the height of the patients (time frame: at the beginning of the treatment, at the end of treatment and 2 years after the treatment). The study lists 2 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 NCT04651049, which also lists 2 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 3 Dec 2020.