Respiratory Distress Syndrome of PrematurityNCT05091840
Cerebral and Renal Oximetry Study in Preterm Patients Who Require Surfactant Administration
An observational study of Respiratory Distress Syndrome of Prematurity, run by Hospital General Universitario Gregorio Marañon.
Trial summary
Respiratory distress syndrome of prematurity (RDSP) is an acute respiratory condition that occurs in preterm infants due to pulmonary surfactant deficiency. Exogenous surfactant administration is a crucial therapeutic measure in the management of RDSP, being the 'less invasive surfactant administration technique'… Read more about this study
- Who is it for?
- Ages 24 to 32 weeks
- Conditions the study is for
- Respiratory Distress Syndrome of Prematurity
- What is being tested?
- oximetry monitoring
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 25 Oct 2021to 30 Aug 2023
- How long will I take part?
- 3 Months
- 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 24 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Patients less than 32 weeks gestational age born in our center (Hospital General Universitario Gregorio Marañon) who require surfactant administration will be included
Who may be able to join
- preterm infants less than 32 weeks gestational age requiring surfactant administration
Who cannot join
- major congenital malformations
- chromosomopathies
Trial locations and contacts
No sites are listed yet.
About this study
Respiratory distress syndrome of prematurity (RDSP) is an acute respiratory condition that occurs in preterm infants due to pulmonary surfactant deficiency.
Exogenous surfactant administration is a crucial therapeutic measure in the management of RDSP, being the 'less invasive surfactant administration technique' (LISA) the gold standard, according to the latest reviews.
Read more
Oximetry based on near-infrared spectroscopy is a non-invasive monitoring modality that provides continuous information on the degree of regional hemoglobin saturation present in the underlying tissue, mainly in the venous compartment. It is thus, a reflection of the balance between oxygen supply and demand of oxygen to the tissues.
We intend to perform a prospective analysis of newborns under 32 weeks of gestational age who require surfactant administration, as we wish to study cerebral and renal perfusion by oximetry in the group of patients who receive surfactant by LISA and in the group of patients who receive surfactant via endotracheal tube (patients intubated at birth for stabilization), since there are few data published in the literature.
Our main hypothesis is that the administration of surfactant by LISA technique does not negatively influence cerebral and renal oximetry.
Our secondary hypothesis is that patients requiring intubation at birth will present greater hemodynamic and respiratory instability in the first 72 hours of life, with a greater decrease in cerebral and renal oximetry with the administration of surfactant, compared to the group that does not require intubation at birth.
- Being tested
- oximetry monitoring
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oximetry monitoringOther
monitoring oximetry in both groups using the INVOS™ system 5100C Oximeter
| Study group | Role | What they receive |
|---|---|---|
| patients requiring intubation at birth and subsequent surfactant administration | Not described Receives: Other: oximetry monitoring | |
| patients who receive surfactant by LISA | Not described Receives: Other: oximetry monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate the impact on cerebral and renal oximetry in preterm infants less than 32 weeks who are administered surfactant
Measured: oximetry monitoring first 24 hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start25 Oct 2021 (estimated)
- Primary completion30 Oct 2022 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome of PrematurityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Gregorio Marañon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Sanchez Luna, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091840
- Sponsor's protocol ID
- Neuro.Neo.4
- Status last verified
- Oct 2021
- First submitted
- 13 Oct 2021
- Last updated
- 25 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bellos I, Fitrou G, Panza R, Pandita A. Comparative efficacy of methods for surfactant administration: a network meta-analysis. Arch Dis Child Fetal Neonatal Ed. 2021 Sep;106(5):474-487. doi: 10.1136/archdischild-2020-319763. Epub 2021 Jan 15.
PubMed 33452218Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Te Pas A, Plavka R, Roehr CC, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GHA, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2019 Update. Neonatology. 2019;115(4):432-450. doi: 10.1159/000499361. Epub 2019 Apr 11.
PubMed 30974433Abdel-Latif ME, Davis PG, Wheeler KI, De Paoli AG, Dargaville PA. Surfactant therapy via thin catheter in preterm infants with or at risk of respiratory distress syndrome. Cochrane Database Syst Rev. 2021 May 10;5(5):CD011672. doi: 10.1002/14651858.CD011672.pub2.
PubMed 33970483Scott JP, Hoffman GM. Near-infrared spectroscopy: exposing the dark (venous) side of the circulation. Paediatr Anaesth. 2014 Jan;24(1):74-88. doi: 10.1111/pan.12301. Epub 2013 Nov 23.
PubMed 24267637Sood BG, McLaughlin K, Cortez J. Near-infrared spectroscopy: applications in neonates. Semin Fetal Neonatal Med. 2015 Jun;20(3):164-72. doi: 10.1016/j.siny.2015.03.008. Epub 2015 Apr 29.
PubMed 25934116Hanke K, Rausch TK, Paul P, Hellwig I, Kramer C, Stichtenoth G, Herz A, Wieg C, Konig IR, Gopel W, Herting E, Hartel C. The effect of less invasive surfactant administration on cerebral oxygenation in preterm infants. Acta Paediatr. 2020 Feb;109(2):291-299. doi: 10.1111/apa.14939. Epub 2019 Sep 5.
PubMed 31310677Bertini G, Coviello C, Gozzini E, Bianconi T, Bresci C, Leonardi V, Dani C. Change of Cerebral Oxygenation during Surfactant Treatment in Preterm Infants: "LISA" versus "InSurE" Procedures. Neuropediatrics. 2017 Apr;48(2):98-103. doi: 10.1055/s-0037-1598647. Epub 2017 Feb 28.
PubMed 28245505Rey-Santano C, Mielgo VE, Gomez-Solaetxe MA, Salomone F, Gastiasoro E, Loureiro B. Cerebral oxygenation associated with INSURE versus LISA procedures in surfactant-deficient newborn piglet RDS model. Pediatr Pulmonol. 2019 May;54(5):644-654. doi: 10.1002/ppul.24277. Epub 2019 Feb 18.
PubMed 30775857Pellicer A, Greisen G, Benders M, Claris O, Dempsey E, Fumagalli M, Gluud C, Hagmann C, Hellstrom-Westas L, Hyttel-Sorensen S, Lemmers P, Naulaers G, Pichler G, Roll C, van Bel F, van Oeveren W, Skoog M, Wolf M, Austin T. The SafeBoosC phase II randomised clinical trial: a treatment guideline for targeted near-infrared-derived cerebral tissue oxygenation versus standard treatment in extremely preterm infants. Neonatology. 2013;104(3):171-8. doi: 10.1159/000351346. Epub 2013 Aug 1.
PubMed 23921600
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral and Renal Oximetry Study in Preterm Patients Who Require Surfactant Administration
- ClinicalTrials.gov ID
- NCT05091840
- Acronym / sponsor ID
- Neuro.Neo.4
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospital General Universitario Gregorio MarañonUniversity, hospital or other
- Study start
- 25 Oct 2021 (estimated)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 25 Oct 2021 (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.
Respiratory distress syndrome of prematurity (RDSP) is an acute respiratory condition that occurs in preterm infants due to pulmonary surfactant deficiency.
Exogenous surfactant administration is a crucial therapeutic measure in the management of RDSP, being the 'less invasive surfactant administration technique' (LISA) the gold standard, according to the latest reviews.
Oximetry based on near-infrared spectroscopy is a non-invasive monitoring modality that provides continuous information on the degree of regional hemoglobin saturation present in the underlying tissue, mainly in the venous compartment. It is thus, a reflection of the balance between oxygen supply and demand of oxygen to the tissues.
We intend to perform a prospective analysis of newborns under 32 weeks of gestational age who require surfactant administration, as we wish to study cerebral and renal perfusion by oximetry in the group of patients who receive surfactant by LISA and in the group of patients who receive surfactant via endotracheal tube (patients intubated at birth for stabilization), since there are few data published in the literature.
Our main hypothesis is that the administration of surfactant by LISA technique does not negatively influence cerebral and renal oximetry.
Our secondary hypothesis is that patients requiring intubation at birth will present greater hemodynamic and respiratory instability in the first 72 hours of life, with a greater decrease in cerebral and renal oximetry with the administration of surfactant, compared to the group that does not require intubation at birth.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients requiring intubation at birth and subsequent surfactant administration | – | Other: oximetry monitoring |
| patients who receive surfactant by LISA | – | Other: oximetry monitoring |
Who may qualify
- Ages
- 24 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients less than 32 weeks gestational age born in our center (Hospital General Universitario Gregorio Marañon) who require surfactant administration will be included
Key inclusion criteria (1 listed)
- preterm infants less than 32 weeks gestational age requiring surfactant administration
Key exclusion criteria (2 listed)
- major congenital malformations
- chromosomopathies
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 |
|---|---|---|
| oximetry monitoringmonitoring oximetry in both groups using the INVOS™ system 5100C Oximeter | Other | patients requiring intubation at birth and subsequent surfactant administration, patients who receive surfactant by LISA |
Primary outcome
to evaluate the impact on cerebral and renal oximetry in preterm infants less than 32 weeks who are administered surfactant
Time frame: oximetry monitoring first 24 hours after birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- Background: PubMed 33452218Bellos I, Fitrou G, Panza R, Pandita A. Comparative efficacy of methods for surfactant administration: a network meta-analysis. Arch Dis Child Fetal Neonatal Ed. 2021 Sep;106(5):474-487. doi: 10.1136/archdischild-2020-319763. Epub 2021 Jan 15.
- Background: PubMed 30974433Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Te Pas A, Plavka R, Roehr CC, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GHA, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2019 Update. Neonatology. 2019;115(4):432-450. doi: 10.1159/000499361. Epub 2019 Apr 11.
- Background: PubMed 33970483Abdel-Latif ME, Davis PG, Wheeler KI, De Paoli AG, Dargaville PA. Surfactant therapy via thin catheter in preterm infants with or at risk of respiratory distress syndrome. Cochrane Database Syst Rev. 2021 May 10;5(5):CD011672. doi: 10.1002/14651858.CD011672.pub2.
- Background: PubMed 24267637Scott JP, Hoffman GM. Near-infrared spectroscopy: exposing the dark (venous) side of the circulation. Paediatr Anaesth. 2014 Jan;24(1):74-88. doi: 10.1111/pan.12301. Epub 2013 Nov 23.
- Background: PubMed 25934116Sood BG, McLaughlin K, Cortez J. Near-infrared spectroscopy: applications in neonates. Semin Fetal Neonatal Med. 2015 Jun;20(3):164-72. doi: 10.1016/j.siny.2015.03.008. Epub 2015 Apr 29.
- Background: PubMed 31310677Hanke K, Rausch TK, Paul P, Hellwig I, Kramer C, Stichtenoth G, Herz A, Wieg C, Konig IR, Gopel W, Herting E, Hartel C. The effect of less invasive surfactant administration on cerebral oxygenation in preterm infants. Acta Paediatr. 2020 Feb;109(2):291-299. doi: 10.1111/apa.14939. Epub 2019 Sep 5.
- Background: PubMed 28245505Bertini G, Coviello C, Gozzini E, Bianconi T, Bresci C, Leonardi V, Dani C. Change of Cerebral Oxygenation during Surfactant Treatment in Preterm Infants: "LISA" versus "InSurE" Procedures. Neuropediatrics. 2017 Apr;48(2):98-103. doi: 10.1055/s-0037-1598647. Epub 2017 Feb 28.
- Background: PubMed 30775857Rey-Santano C, Mielgo VE, Gomez-Solaetxe MA, Salomone F, Gastiasoro E, Loureiro B. Cerebral oxygenation associated with INSURE versus LISA procedures in surfactant-deficient newborn piglet RDS model. Pediatr Pulmonol. 2019 May;54(5):644-654. doi: 10.1002/ppul.24277. Epub 2019 Feb 18.
- Background: PubMed 23921600Pellicer A, Greisen G, Benders M, Claris O, Dempsey E, Fumagalli M, Gluud C, Hagmann C, Hellstrom-Westas L, Hyttel-Sorensen S, Lemmers P, Naulaers G, Pichler G, Roll C, van Bel F, van Oeveren W, Skoog M, Wolf M, Austin T. The SafeBoosC phase II randomised clinical trial: a treatment guideline for targeted near-infrared-derived cerebral tissue oxygenation versus standard treatment in extremely preterm infants. Neonatology. 2013;104(3):171-8. doi: 10.1159/000351346. Epub 2013 Aug 1.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress Syndrome of Prematurity, run by Hospital General Universitario Gregorio Marañon.
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 25 Oct 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manuel Sanchez Luna (34 91 529 00 18, msluna@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to evaluate the impact on cerebral and renal oximetry in preterm infants less than 32 weeks who are administered surfactant (time frame: oximetry monitoring first 24 hours after birth). 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 NCT05091840, which also lists 9 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 25 Oct 2021.