Respiratory Distress Syndrome, Newborn Clinical Trial
— LUNGOfficial title:
Lung UltrasouNd Guided Surfactant Therapy in Preterm Infants: an International Multicentric Randomized Control Trial (LUNG Study)
NCT number | NCT05198375 |
Other study ID # | 302/2021 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 5, 2022 |
Est. completion date | July 31, 2024 |
The investigators hypothesized that the use of lung ultrasound (LU) for measuring RDS severity and deciding surfactant treatment thresholds might decrease the incidence of early and late sequelae in the study group. Thus, a timely surfactant therapy would eventually improve short (e.g. Need of mechanical ventilation in the first 3 days) and more long-term outcomes, such as BPD or death. To confirm this hypothesis, the investigators planned an international multicenter randomized controlled study in which preterm infants will be randomized into two groups: one will be managed deciding surfactant treatment of preterm infants with RDS on the basis of a cut-off value of FiO2 as for European guidelines, and one will be managed deciding surfactant treatment using a LU score cut-off and/or FiO2. Primary endpoint will be the reduction in proportion of infants with BPD or death in the group managed with LU compared to the control group
Status | Recruiting |
Enrollment | 668 |
Est. completion date | July 31, 2024 |
Est. primary completion date | January 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Minute to 3 Hours |
Eligibility | Inclusion Criteria: 1. In-born infants at 25+0-29+6 weeks of gestational age 2. Spontaneously breathing at birth but requiring noninvasive respiratory support with nCPAP at a pressure of 6-8 cmH2O to maintain an SpO2 between 90% and 95%. 3. Parental consent has been obtained 4. Exclusion of causes of respiratory failure other than RDS Exclusion Criteria: 1. Endotracheal intubation in the delivery room for resuscitation or insufficient respiratory drive according to European guidelines 2. Prolonged premature rupture of membranes (PROM) for more than 3 days 3. Presence of major congenital malformations or chromosomal anomalies 4. Hydrops fetalis 5. Inherited disorders of metabolism 6. Administration of surfactant before performing the LUS. 7. Other respiratory diseases than RDS |
Country | Name | City | State |
---|---|---|---|
Italy | Neonatal intensive care unit - Azienda Sanitaria dell'Alto Adige | Bolzano | |
Italy | Spedali Civili di Brescia | Brescia | |
Italy | AOU Careggi | Florence | |
Italy | Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano | Milano | |
Italy | Neonatal Intensive Care Unit Ospedale dei Bambini "Vittore Buzzi" | Milano | |
Italy | Neonatal Intensive Care Unit Modena | Modena | |
Italy | Neonatal Intensive Care Unit - Federico II University | Napoli | |
Italy | Azienda Ospedaliero-Universitaria Pisana | Pisa | |
Italy | Neonatologia e Terapia Intensiva Neonatale Rimini | Rimini | |
Italy | Fondazione Policlinico Gemelli | Roma | |
Italy | Azienda sanitaria universitaria Friuli Centrale | Udine | |
Spain | Germans Trias i Pujol | Badalona | |
Spain | Barcelona Center for Maternal Fetal and Neonatal Medicine | Barcelona | |
Spain | Neonatal Intensive Care Unit, Puerta del Mar Universitary Hospital, Cádiz. | Cadiz | |
Spain | Neonatal Intensive Care Unit Coruña | Coruña | |
Spain | Hospital Gregorio Maranon | Madrid | |
Spain | Hospital Alvaro Cunqueiro de Vigo. Instituto de Investigación Galicia Sur | Vigo |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliero-Universitaria Careggi |
Italy, Spain,
Bahadue FL, Soll R. Early versus delayed selective surfactant treatment for neonatal respiratory distress syndrome. Cochrane Database Syst Rev. 2012 Nov 14;11(11):CD001456. doi: 10.1002/14651858.CD001456.pub2. — View Citation
Bell MJ, Ternberg JL, Feigin RD, Keating JP, Marshall R, Barton L, Brotherton T. Neonatal necrotizing enterocolitis. Therapeutic decisions based upon clinical staging. Ann Surg. 1978 Jan;187(1):1-7. doi: 10.1097/00000658-197801000-00001. — View Citation
Brat R, Yousef N, Klifa R, Reynaud S, Shankar Aguilera S, De Luca D. Lung Ultrasonography Score to Evaluate Oxygenation and Surfactant Need in Neonates Treated With Continuous Positive Airway Pressure. JAMA Pediatr. 2015 Aug;169(8):e151797. doi: 10.1001/j — View Citation
Corsini I, Parri N, Ficial B, Dani C. Lung ultrasound in the neonatal intensive care unit: Review of the literature and future perspectives. Pediatr Pulmonol. 2020 Jul;55(7):1550-1562. doi: 10.1002/ppul.24792. Epub 2020 Apr 27. — View Citation
De Luca D, van Kaam AH, Tingay DG, Courtney SE, Danhaive O, Carnielli VP, Zimmermann LJ, Kneyber MCJ, Tissieres P, Brierley J, Conti G, Pillow JJ, Rimensberger PC. The Montreux definition of neonatal ARDS: biological and clinical background behind the des — View Citation
De Martino L, Yousef N, Ben-Ammar R, Raimondi F, Shankar-Aguilera S, De Luca D. Lung Ultrasound Score Predicts Surfactant Need in Extremely Preterm Neonates. Pediatrics. 2018 Sep;142(3):e20180463. doi: 10.1542/peds.2018-0463. Epub 2018 Aug 14. — View Citation
de Vries LS, Eken P, Dubowitz LM. The spectrum of leukomalacia using cranial ultrasound. Behav Brain Res. 1992 Jul 31;49(1):1-6. doi: 10.1016/s0166-4328(05)80189-5. — View Citation
International Committee for the Classification of Retinopathy of Prematurity. The International Classification of Retinopathy of Prematurity revisited. Arch Ophthalmol. 2005 Jul;123(7):991-9. doi: 10.1001/archopht.123.7.991. — View Citation
Jobe AH, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med. 2001 Jun;163(7):1723-9. doi: 10.1164/ajrccm.163.7.2011060. No abstract available. — View Citation
Madar J, Roehr CC, Ainsworth S, Ersdal H, Morley C, Rudiger M, Skare C, Szczapa T, Te Pas A, Trevisanuto D, Urlesberger B, Wilkinson D, Wyllie JP. European Resuscitation Council Guidelines 2021: Newborn resuscitation and support of transition of infants a — View Citation
Raimondi F, Migliaro F, Corsini I, Meneghin F, Dolce P, Pierri L, Perri A, Aversa S, Nobile S, Lama S, Varano S, Savoia M, Gatto S, Leonardi V, Capasso L, Carnielli VP, Mosca F, Dani C, Vento G, Lista G. Lung Ultrasound Score Progress in Neonatal Respirat — View Citation
Raimondi F, Migliaro F, Corsini I, Meneghin F, Pierri L, Salome S, Perri A, Aversa S, Nobile S, Lama S, Varano S, Savoia M, Gatto S, Leonardi V, Capasso L, Carnielli VP, Mosca F, Dani C, Vento G, Dolce P, Lista G. Neonatal Lung Ultrasound and Surfactant A — View Citation
Raschetti R, Yousef N, Vigo G, Marseglia G, Centorrino R, Ben-Ammar R, Shankar-Aguilera S, De Luca D. Echography-Guided Surfactant Therapy to Improve Timeliness of Surfactant Replacement: A Quality Improvement Project. J Pediatr. 2019 Sep;212:137-143.e1. — View Citation
Rodriguez-Fanjul J, Jordan I, Balaguer M, Batista-Munoz A, Ramon M, Bobillo-Perez S. Early surfactant replacement guided by lung ultrasound in preterm newborns with RDS: the ULTRASURF randomised controlled trial. Eur J Pediatr. 2020 Dec;179(12):1913-1920. — View Citation
Sweet 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. Neonatol — View Citation
* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | BPD or Death reduction | Primary endpoint will be the difference in proportion of infants with BPD (defined as Bancalari, Jobe 2001) or death in the group managed with LUS compared to the control group. | 36 weeks of gestational age or at the moment of discharge | |
Secondary | Proportion of infants treated "early" (before 3 hours of life) vs late | Percent of infants treated within 3 hours of life vs late | First 3 hours of life | |
Secondary | Age in minute at the first surfactant administration | Minutes | First 12 hours of life | |
Secondary | Needs of mechanical ventilation in the first 3 days of life | Percent of infants needed mechanical ventilation within 3 days of life | First 3 days of life | |
Secondary | Max FiO2 value before surfactant treatment | FiO2 value | First 12 hours of life | |
Secondary | FiO2/SpO2 ratio before surfactant treatment | FiO2/SpO2 ratio | First 12 hours of life | |
Secondary | Duration of non-invasive and invasive respiratory support (included O2 therapy) | Days | Participants will be followed for the duration of hospital stay, an expected average of 12 weeks | |
Secondary | Proportion of infants needed to receive multiple doses of surfactant | Percentage | Participants will be followed for the duration of hospital stay, an expected average of 12 weeks | |
Secondary | Duration of hospitalization | Days | Participants will be followed for the duration of hospital stay, an expected average of 12 weeks | |
Secondary | Occurrence of BPD using multiple definitions | Proportion | Participants will be followed for the duration of hospital stay, an expected average of 12 weeks | |
Secondary | Proportion of infants with patent ductus arteriosus treated pharmacologically and/or surgically | Percentage | Participants will be followed for the duration of hospital stay, an expected average of 12 weeks | |
Secondary | Proportion of infants with pneumothorax | Percentage | Participants will be followed for the duration of hospital stay, an expected average of 12 weeks | |
Secondary | Proportion of infants with retinopathy of prematurity | Percentage | Participants will be followed for the duration of hospital stay, an expected average of 12 weeks | |
Secondary | Proportion of infants with intraventricular hemorrhage > or = grade 3 | Percentage | Participants will be followed for the duration of hospital stay, an expected average of 12 weeks | |
Secondary | Proportion of infants with periventricular leukomalacia | Percentage | Participants will be followed for the duration of hospital stay, an expected average of 12 weeks | |
Secondary | Proportion of infants with necrotizing enterocolitis > stage 2 | Percentage | Participants will be followed for the duration of hospital stay, an expected average of 12 weeks | |
Secondary | Use of systemic postnatal steroids | Percentage | Participants will be followed for the duration of hospital stay, an expected average of 12 weeks | |
Secondary | Mortality | Percentage | Participants will be followed for the duration of hospital stay, an expected average of 12 weeks | |
Secondary | Pulmonary hemorrhage | Percentage | Participants will be followed for the duration of hospital stay, an expected average of 12 weeks |
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