Persistent Ductus ArteriosusPhase 3IBU24h-EchoGNCT04282941
Clinical Trial to Evaluate Two Guidelines for the Administration of Ibuprofen in the Treatment of Persistent Ductus Arteriosus Eco-guided: Impact in the Intestinal Prognosis
A Phase 3 study testing Ibuprofen in continuous (24 hours) iv infusion and EchoG and IV bolus Ibuprofen slow (15 minutes) and EchoG in people with Persistent Ductus Arteriosus, run by Instituto de Investigación Hospital Universitario La Paz at 3 sites in Spain.
Trial summary
Persistent ductus arteriosus (DA) is a common entity in the premature newborn and is associated with high morbidity and mortality. There is still controversy about which is the best treatment for its closure. Read more about this study
- Who is it for?
- Ages 0 minutes to 33 weeks
- Conditions the study is for
- Persistent Ductus Arteriosus
- What is being tested?
- Ibuprofen in continuous (24 hours) iv infusion and EchoG and IV bolus Ibuprofen slow (15 minutes) and EchoG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 3 sitesSpain
- Study dates
- 20 Feb 2017to 30 Nov 2020
- Phase
- Phase 3
- 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 0 minutes to 33 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants with less 33 weeks of gestational age
- DA ≥ 1.5 mm with decision to start pharmacological treatment
- Informed consent signed by the legal representative
Who cannot join
- Consent denied
- Presence of serious congenital alterations
- Congenital heart disease
- Contraindication for the administration of IB: oligoanuria (diuresis <1cc / kg / h), bleeding severe recent intraventricular (HIV grade III or extensive periventricular hemorrhagic infarction), serum creatinine> 1.5 mg / dl or clinical suspicion of intestinal ischemia.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites, 3 recruiting
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
Maria Carmen Bravo Laguna, Dr., +34917277416, mcarmen.bravo@salud.madrid.org
Paloma Moraga Alapont, paloma.ucicec@gmail.com
- Recruiting
Hospital 12 de Octubre
Madrid
Fernando Cabañas, 913 90 80 00, fernando.cabanas@quironsalud.es
- Recruiting
Hospital Quirón Salud Madrid
Madrid
Fernando Cabañas, 914 52 19 00, fernando.cabanas@quironsalud.es
About this study
Official title: Phase III Clinical Trial, Randomized, Multicentre, Double Blind to Evaluate Two Guidelines for the Administration of Ibuprofen in the Treatment of Persistent Ductus Arteriosus Eco-guided: Impact in the Intestinal Prognosis
Persistent ductus arteriosus (DA) is a common entity in the premature newborn and is associated with high morbidity and mortality. There is still controversy about which is the best treatment for its closure. Children with AD who receive pharmacological treatment present more frequently than other premature children, necrotizing enterocolitis or isolated intestinal perforation.
At the present time, the conventional treatment of DA consists in the administration of intravenous ibuprofen, slow bolus in 3 daily doses 10-5-5 mg / kg / day. Recently, it has been observed that treatment with ibuprofen in continuous iv infusion for 3 days seems to be more effective in closing DA than conventional treatment for 3 days with the same dose but in slow iv bolus. This experimental treatment reduced the incidence of associated necrotizing enterocolitis. Our group demonstrated in a previous pilot trial that the guided treatment with echocardiography (EchoG) of DA with ibuprofen compared with conventional treatment, allows to reduce the number of doses to the patient. The EchoG treatment thus presents a potential reduction of side effects associated with medication, this resulted in a tendency to have a lower incidence of necrotising enterocolitis in the experimental group. This multicenter clinical trial aims to test the hypothesis that the combination of 2 experimental treatments, the use of ibuprofen in continuous perfusion and EchoG, reduces the incidence of digestive side effects (necrotising enterocolitis or isolated intestinal perforation) compared to the treatment also guided by echocardiography but slow bolus iv.
- Conditions
- Persistent Ductus Arteriosus
- Being tested
- Ibuprofen in continuous (24 hours) iv infusion and EchoG, IV bolus Ibuprofen slow (15 minutes) and EchoG
- 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.
Ibuprofen in continuous (24 hours) iv infusion and EchoGDrug
The first dose of ibuprofen will be 10 mg / kg to be administered as a continuous infusion for 24 hours. An echocardiogram will be performed before each of the following 2 doses of 5 mg / Kg and will only be administered if it meets echocardiographic criteria that indicate open DA (observation of ductus permeability with color Doppler regardless of its size). Each dose will be administered as a 24-hour continuous infusion.
IV bolus Ibuprofen slow (15 minutes) and EchoGDrug
The first dose of ibuprofen of 10 mg / Kg to be administered in slow iv bolus (15 minutes). Before each of the following 2 doses of 5 mg / Kg, echocardiography will be performed and will only be administered if it meets the echocardiographic criteria indicated by open DA (observation of ductus permeability in color Doppler regardless of its size). Each dose will be administered in iv boluses in 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen in continuous (24 hours) iv infusion and EchoG | Experimental | The first dose of ibuprofen will be 10 mg / kg to be administered as a continuous infusion for 24 hours. An echocardiogram will be performed before each of the following 2 doses of 5 mg / Kg and will only be administered if it meets echocardiographic criteria that indicate open DA (observation of ductus permeability with color Doppler regardless of its size). Each dose will be administered as a 24-hour continuous infusion. Receives: Drug: Ibuprofen in continuous (24 hours) iv infusion and EchoG |
| IV bolus Ibuprofen slow (15 minutes) and EchoG | Experimental | The first dose of ibuprofen of 10 mg / Kg to be administered in slow iv bolus (15 minutes). Before each of the following 2 doses of 5 mg / Kg, echocardiography will be performed and will only be administered if it meets the echocardiographic criteria indicated by open DA (observation of ductus permeability in color Doppler regardless of its size). Each dose will be administered in iv boluses in 15 minutes Receives: Drug: IV bolus Ibuprofen slow (15 minutes) and EchoG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change the incidence of necrotizing enterocolitis or isolated intestinal perforation in preterm infants receiving treatment for closure of AD with ibuprofen in continuous IV perfusion and EchoG vs iv and EchoG boluses
Change the incidence of necrotizing enterocolitis or isolated intestinal perforation in preterm infants receiving treatment for closure of AD with ibuprofen in continuous IV perfusion and EchoG vs iv and EchoG boluses
Measured: 40 weeks
Secondary outcomes (1)
To Identify genetic polymorphisms asociated to refractory medical treatment of AD and in those most vulnerable to presenting necrotizing enterocolitis or isolated intestinal perforation.
Identify genetic polymorphisms in patients refractory to medical treatment of AD and in those most vulnerable to presenting necrotizing enterocolitis or isolated intestinal perforation.
Measured: Day 0(Visit 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start20 Feb 2017
- Primary completion30 Jan 2020
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Ductus ArteriosusStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Administration schedule A: Ibuprofen in continuous iv infusion and EchoG. Each cycle will be 3 doses. Administration schedule B: slow iv bolus Ibuprofen and EchoG. Each cycle will be 3 doses.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282941
- Sponsor's protocol ID
- 2016-002974-11
- Other IDs
- 2016
- Acronym
- IBU24h-EchoG
- Status last verified
- Jul 2020
- First submitted
- 5 Feb 2020
- Last updated
- 29 Oct 2020
- Results posted
- 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 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Clinical Trial, Randomized, Multicentre, Double Blind to Evaluate Two Guidelines for the Administration of Ibuprofen in the Treatment of Persistent Ductus Arteriosus Eco-guided: Impact in the Intestinal Prognosis
- ClinicalTrials.gov ID
- NCT04282941
- Acronym / sponsor ID
- IBU24h-EchoG / 2016-002974-11
- Conditions
- Persistent Ductus Arteriosus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 25 Feb 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.
Persistent ductus arteriosus (DA) is a common entity in the premature newborn and is associated with high morbidity and mortality. There is still controversy about which is the best treatment for its closure. Children with AD who receive pharmacological treatment present more frequently than other premature children, necrotizing enterocolitis or isolated intestinal perforation.
At the present time, the conventional treatment of DA consists in the administration of intravenous ibuprofen, slow bolus in 3 daily doses 10-5-5 mg / kg / day. Recently, it has been observed that treatment with ibuprofen in continuous iv infusion for 3 days seems to be more effective in closing DA than conventional treatment for 3 days with the same dose but in slow iv bolus. This experimental treatment reduced the incidence of associated necrotizing enterocolitis. Our group demonstrated in a previous pilot trial that the guided treatment with echocardiography (EchoG) of DA with ibuprofen compared with conventional treatment, allows to reduce the number of doses to the patient. The EchoG treatment thus presents a potential reduction of side effects associated with medication, this resulted in a tendency to have a lower incidence of necrotising enterocolitis in the experimental group. This multicenter clinical trial aims to test the hypothesis that the combination of 2 experimental treatments, the use of ibuprofen in continuous perfusion and EchoG, reduces the incidence of digestive side effects (necrotising enterocolitis or isolated intestinal perforation) compared to the treatment also guided by echocardiography but slow bolus iv.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Administration schedule A: Ibuprofen in continuous iv infusion and EchoG. Each cycle will be 3 doses. Administration schedule B: slow iv bolus Ibuprofen and EchoG. Each cycle will be 3 doses.
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen in continuous (24 hours) iv infusion and EchoG | Experimental | Drug: Ibuprofen in continuous (24 hours) iv infusion and EchoGThe first dose of ibuprofen will be 10 mg / kg to be administered as a continuous infusion for 24 hours. An echocardiogram will be performed before each of the following 2 doses of 5 mg / Kg and will only be administered if it meets echocardiographic criteria that indicate open DA (observation of ductus permeability with color Doppler regardless of its size). Each dose will be administered as a 24-hour continuous infusion. |
| IV bolus Ibuprofen slow (15 minutes) and EchoG | Experimental | Drug: IV bolus Ibuprofen slow (15 minutes) and EchoGThe first dose of ibuprofen of 10 mg / Kg to be administered in slow iv bolus (15 minutes). Before each of the following 2 doses of 5 mg / Kg, echocardiography will be performed and will only be administered if it meets the echocardiographic criteria indicated by open DA (observation of ductus permeability in color Doppler regardless of its size). Each dose will be administered in iv boluses in 15 minutes |
Who may qualify
- Ages
- 0 minutes to 33 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Preterm infants with less 33 weeks of gestational age
- DA ≥ 1.5 mm with decision to start pharmacological treatment
- Informed consent signed by the legal representative
Key exclusion criteria (4 listed)
- Consent denied
- Presence of serious congenital alterations
- Congenital heart disease
- Contraindication for the administration of IB: oligoanuria (diuresis <1cc / kg / h), bleeding severe recent intraventricular (HIV grade III or extensive periventricular hemorrhagic infarction), serum creatinine> 1.5 mg / dl or clinical suspicion of intestinal ischemia.
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 |
|---|---|---|
| Ibuprofen in continuous (24 hours) iv infusion and EchoGThe first dose of ibuprofen will be 10 mg / kg to be administered as a continuous infusion for 24 hours. An echocardiogram will be performed before each of the following 2 doses of 5 mg / Kg and will only be administered if it meets echocardiographic criteria that indicate open DA (observation of ductus permeability with color Doppler regardless of its size). Each dose will be administered as a 24-hour continuous infusion. | Drug | Ibuprofen in continuous (24 hours) iv infusion and EchoG |
| IV bolus Ibuprofen slow (15 minutes) and EchoGThe first dose of ibuprofen of 10 mg / Kg to be administered in slow iv bolus (15 minutes). Before each of the following 2 doses of 5 mg / Kg, echocardiography will be performed and will only be administered if it meets the echocardiographic criteria indicated by open DA (observation of ductus permeability in color Doppler regardless of its size). Each dose will be administered in iv boluses in 15 minutes | Drug | IV bolus Ibuprofen slow (15 minutes) and EchoG |
Primary outcome
Change the incidence of necrotizing enterocolitis or isolated intestinal perforation in preterm infants receiving treatment for closure of AD with ibuprofen in continuous IV perfusion and EchoG vs iv and EchoG boluses
Time frame: 40 weeks
Change the incidence of necrotizing enterocolitis or isolated intestinal perforation in preterm infants receiving treatment for closure of AD with ibuprofen in continuous IV perfusion and EchoG vs iv and EchoG boluses
1 secondary outcome
To Identify genetic polymorphisms asociated to refractory medical treatment of AD and in those most vulnerable to presenting necrotizing enterocolitis or isolated intestinal perforation.
Time frame: Day 0(Visit 1)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ibuprofen in continuous (24 hours) iv infusion and EchoG and IV bolus Ibuprofen slow (15 minutes) and EchoG in people with Persistent Ductus Arteriosus, run by Instituto de Investigación Hospital Universitario La Paz at 3 sites in Spain.
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 3 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: status not confirmed, as of the sponsor's last update on 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change the incidence of necrotizing enterocolitis or isolated intestinal perforation in preterm infants receiving treatment for closure of AD with ibuprofen in continuous IV perfusion and EchoG vs iv and EchoG boluses (time frame: 40 weeks). 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 29 Oct 2020.