Patent Ductus Arteriosus After Premature BirthNCT03675425
The Effects of Phototherapy in Preterm Infants Pda
A study testing Group 1: non chest shielding and Group 2: chest shielding in people with Patent Ductus Arteriosus After Premature Birth and Hyper Bilirubinemia, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
The study was designed to assess whether chest shielding during phototherapy reduces the incidence of PDA, as assessed by serial echocardiographic examinations, in a population of extremely preterm infants born at lower 30 week gestation. Read more about this study
- Who is it for?
- Ages 3 days to 1 week
- Conditions the study is for
- Patent Ductus Arteriosus After Premature Birth, Hyper Bilirubinemia
- What is being tested?
- Group 1: non chest shielding and Group 2: chest shielding
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jul 2018to 28 Feb 2019
- 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 3 days to 1 week
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational week ≤ 30 weeks receiving phototherapy due to jaundice and infants who can perform echocardiography before and after treatment will be included in the study.
Who cannot join
- Babies with congenital heart disease.
- Infants with major structural anomalies and infants who can not undergo echocardiography before or after treatment.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zekai Tahir Burak Matarnity Teaching
Ankara, 06230
About this study
Official title: Chest Shielding for Prevention of a Patent Ductus Arteriosus in Preterm Infants Receiving Phototherapy Effect of Phototherapy
The study was designed to assess whether chest shielding during phototherapy reduces the incidence of PDA, as assessed by serial echocardiographic examinations, in a population of extremely preterm infants born at lower 30 week gestation.
Read the detailed description
Phototherapy is a therapeutic intervention frequently used for management of neonatal hyperbilirubinaemia in extremely premature infants, especially in the first week when patency of the ductus is a clinical problem. Phototherapy has also been implicated in increased ductal patency. One randomized, controlled trial showed that chest shielding during phototherapy reduced the incidence and severity of PDA by 50% in preterm infants. These findings were mainly based on clinical evaluation of the ductus with echocardiographic studies performed only on a subgroup of infants noted to have a murmur on clinical examination.
- Being tested
- Group 1: non chest shielding, Group 2: chest shielding
- Keywords
- Chest shielding, Patent Ductus Arteriosus, Chest Childing
- Medical subject headings
- Ductus Arteriosus, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1: non chest shieldingOther
non chest childin: infants will be randomized into two different phototherapy groups eco with pad diameter will be measured in before and after phototherapy,
Group 2: chest shieldingOther
chest childing: infants will be randomized into two different phototherapy groups eco with pad diameter will be measured in before and after phototherapy,
| Study group | Role | What they receive |
|---|---|---|
| Group 1: non chest shielding | Experimental | non chest shielding generic name: non dosage: non frequency and duration: in first 48 h eco with pad diameter will be measured in before and after phototherapy, Receives: Other: Group 1: non chest shielding |
| Group 2: chest shielding | Placebo comparator | chest shielding generic name: Phototrephy dosage: non frequency and duration: in first 48 h echo with pad diameter will be measured in before and after phototherapy, Receives: Other: Group 2: chest shielding |
What is being measured
The primary outcome is the main question the study is designed to answer.
echocardiographic examination
presence of Patent Ductus arteriozus
Measured: first week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start8 Jul 2018
- Primary completion30 Jan 2019 (estimated)
- Study completion28 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patent Ductus Arteriosus After Premature BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evrim Alyamaç Dizdar, MD, Study director, zekai tahir burak matarnity teaching hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675425
- Sponsor's protocol ID
- 148/2017
- Status last verified
- Jul 2018
- First submitted
- 15 Jul 2018
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chest Shielding for Prevention of a Patent Ductus Arteriosus in Preterm Infants Receiving Phototherapy Effect of Phototherapy
- ClinicalTrials.gov ID
- NCT03675425
- Acronym / sponsor ID
- 148/2017
- Keywords
- Chest shielding, Patent Ductus Arteriosus, Chest Childing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Study start
- 8 Jul 2018 (actual)
- Primary completion
- 30 Jan 2019 (estimated)
- Study completion
- 28 Feb 2019 (estimated)
- First posted
- 18 Sep 2018 (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 was designed to assess whether chest shielding during phototherapy reduces the incidence of PDA, as assessed by serial echocardiographic examinations, in a population of extremely preterm infants born at lower 30 week gestation.
Detailed description
Phototherapy is a therapeutic intervention frequently used for management of neonatal hyperbilirubinaemia in extremely premature infants, especially in the first week when patency of the ductus is a clinical problem. Phototherapy has also been implicated in increased ductal patency. One randomized, controlled trial showed that chest shielding during phototherapy reduced the incidence and severity of PDA by 50% in preterm infants. These findings were mainly based on clinical evaluation of the ductus with echocardiographic studies performed only on a subgroup of infants noted to have a murmur on clinical examination.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: non chest shielding | Experimental | Other: Group 1: non chest shieldingnon chest shielding generic name: non dosage: non frequency and duration: in first 48 h eco with pad diameter will be measured in before and after phototherapy, |
| Group 2: chest shielding | Placebo comparator | Other: Group 2: chest shieldingchest shielding generic name: Phototrephy dosage: non frequency and duration: in first 48 h echo with pad diameter will be measured in before and after phototherapy, |
Who may qualify
- Ages
- 3 days to 1 week
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Gestational week ≤ 30 weeks receiving phototherapy due to jaundice and infants who can perform echocardiography before and after treatment will be included in the study.
Key exclusion criteria (2 listed)
- Babies with congenital heart disease.
- Infants with major structural anomalies and infants who can not undergo echocardiography before or after treatment.
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 1: non chest shieldingnon chest childin: infants will be randomized into two different phototherapy groups eco with pad diameter will be measured in before and after phototherapy, | Other | Group 1: non chest shielding |
| Group 2: chest shieldingchest childing: infants will be randomized into two different phototherapy groups eco with pad diameter will be measured in before and after phototherapy, | Other | Group 2: chest shielding |
Primary outcome
echocardiographic examination
Time frame: first week
presence of Patent Ductus arteriozus
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Patent Ductus Arteriosus After Premature Birth
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Patent Ductus Arteriosus After Premature Birth
Active, not recruitingPhase 3
Management of the PDA Trial
Infant, Premature, Patent Ductus Arteriosus
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.
Evrim Alyamaç Dizdar, MD study director
zekai tahir burak matarnity teaching 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 Group 1: non chest shielding and Group 2: chest shielding in people with Patent Ductus Arteriosus After Premature Birth and Hyper Bilirubinemia, run by Zekai Tahir Burak Women's Health Research and Education Hospital 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 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2018. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
echocardiographic examination (time frame: first week). 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 11 Dec 2018.