Lung UltrasouNd Guided Surfactant Therapy in Preterm Infants (LUNG Study)
NCT ID: NCT05198375
Last Updated: 2025-05-29
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
TERMINATED
Clinical Phase
NA
Total Enrollment
411 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-04-05
Study Completion Date
2025-05-23
Brief Summary
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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
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
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Detailed Description
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Background Management of neonatal respiratory distress syndrome (RDS) involves noninvasive respiratory supports, such as nasal continuous positive airway (nCPAP), and mechanical ventilation. On the other hand, exogenous surfactant administration is the other cornerstone for the treatment of RDS. Currently, the decision to administer surfactant in a non-invasively ventilated newborn is commonly based on cut-off values of inspired fraction of oxygen (FiO2). Nevertheless, the accuracy of this criterion might be weak because FiO2 values depend per se by the setting of respiratory support. Moreover, the American Academy of Pediatrics guidelines do not recommend any FiO2 threshold for surfactant administration. It has been shown that prompt administration of surfactant (within the first 3 hours of life) can reduce the risk of bronchopulmonary dysplasia (BPD). Unfortunately, criteria for surfactant treatment used, often leads to a delayed administration. The role of lung ultrasound (LU) as a semi-quantitative method for the decision to give exogenous surfactant has been studied in recent years. Researchers demonstrated that a LU score (LUS) of RDS severity is able to predict the need for surfactant therapy, as subsequently confirmed by subsequent studies. After these results, a first quality improvement study demonstrated that the use of a LUS cut-off for deciding surfactant treatment allowed a significant increase of early administration. This finding has been confirmed by a recent single-center randomized controlled trial. However, all these studies were single-center, and there are not multicenter randomized controlled trials which can support the wide use of LUS measurement as a standard method for surfactant replacement therapy.
This study, in addition to investigating the decision-making role of LUS in the administration of surfactant, also aims to evaluate the possibility of making treatment with surfactant earlier and more timely, having already been shown in the past that an early administration improves clinical outcomes.
Aim of the study The investigators hypothesized that the use of a LUS 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 (CG), and one will be managed deciding surfactant treatment using a LUS cut-off and FiO2 (LUSG).
Study design The study will be a multicenter randomized open control trial carried out in Level III-IV neonatal intensive care units (NICUs). The financial outcome of the study is no profit. The design of the study is of superiority. The enrollment period will be 24 months (starting February 1, 2022).
Study population The study will take place within the NICUs and therefore in a hospital setting. The study will be multicenter.
The total number of enrolled infants will be 668 (334 per arm). Each center will have to enroll a minimum of 10 children and a maximum of 70.
An interim analysis will be conducted after 167 infants enrolled in each arm (334 total infants enrolled).
Management in the delivery room and in the first hour of life Positive pressure with a neonatal mask and a T-piece system (Neopuff Infant Resuscitator ®, Fisher and Paykel, Auckland, New Zealand) will be used to stabilize the newborns after birth as per routine daily practice. If necessary, infants will start mechanical ventilation in agreement with the European guidelines on neonatal resuscitation. In this latter case the babies will be excluded from the study (see Exclusion criteria section).
In order to better standardize the timing of care after birth, it is expected that assistance in the delivery room, transfer of the newborn to the intensive care unit, stabilization of the newborn and the related procedures (positioning of the vascular access, stabilization of ventilatory parameters, thermal stabilization, etc.) are completed within the first hour of life.
Once infants with RDS have been screened, enrolled in the study, and allocated to the CG or LUSG, LU will be performed as soon as possible between 1 and 3 hours life (\<3 h of life). In the meantime, the newborns will be assisted in noninvasive ventilation (nCPAP, pressure 6-8 cmH20) and oxygen to maintain preductal oxygen saturation (SpO2) between 90 and 95%. A loading dose of caffeine citrate of 20 mg/kg will be administered in the first hours of life followed by a maintenance of 5 mg/kg/day, as per routine clinical practice.
Noninvasive ventilation management after the first 3 hours of life or after surfactant administration After the first three hours of life or after having administered surfactant, according to the criteria provided by the randomization group, the newborns can be assisted with non-invasive ventilation other than nCPAP (NIPPV, BiPAP, HFNC) according to the care protocol of the centers involved in the study.
Lung ultrasound procedure LU will be performed by the attending physician. Centers participating to the study should be routinely using LU and all the physician are already trained for the use of the technique.
LUS will be calculated by performing longitudinal scans of the chest in the anterior (midclavicular line), lateral (anterior axillary line) and posterior (posterior axillary line) area bilaterally using high-frequency linear or micro linear (hockey stick) probe between 1 and 3 hour of life. The focus will be located at the level of the pleural line. A score from 0 to 3 will be assigned to each scan area based on the ultrasound detected pattern (in case of different score pattern in the same area the worst will be the one chosen).
LU can be performed keeping the patient in the supine position without the need to rotate him as the posterior axillary line is accessible from the side of the newborn.
Surfactant replacement therapy should be given if LUS is 9 or more in the babies recruited to the LUSG.
The LUS group will receive as rescue therapy surfactant administration in case of LUS \< or = 8 but FiO2\> 0.30 on nCPAP (pressure 6-8 cmH20) to maintain preductal SpO2 between 90 and 95%.
Surfactant treatment Once criteria for surfactant administration have been reached, surfactant (Curosurf ®, Chiesi, Parma, Italy) will be given (200 mg/kg) according to the InSURE (Intubate-SURfactant-Extubate), LISA (Less- Invasive-Surfactant-Administration) or IN-REC-SURE (INtubate-RECruit-SURfactant-Extubate) technique in both the groups as per the enrollment center protocol.
Pharmacological premedication with fentanest and/or atropine will be allowed (as per center protocol) and recorded.
After surfactant administration, the babies of both groups will be extubated if it has been performed the InSURE or IN-REC-SURE method within 30 min (if satisfactory respiratory drive is present) and will receive nCPAP (pressure 6-8 cmH2O) as per center protocol .
Infants of both groups can receive a subsequent dose of surfactant (100 mg/kg of poractant alfa) using the same method if they meet the non-invasive ventilation failure criteria again during the following 12 to 24 h.
nCPAP ventilation failure criteria In the NICU, nCPAP will be the standard method of noninvasive support in all infants recruited to this trial. nCPAP failure is defined if any of the following criteria are met: FiO2 ≥ 0.30 to maintain a SpO2\> 90 for at least 30 min unless rapid clinical deterioration has occurred; respiratory acidosis defined as pCO2 \> 65 mmHg (8.5 kPa) and pH \<7.20 on an arterial or capillary blood gas sample; apnea defined as more than four episodes of apnea per hour or more than two episodes of apnea per hour when ventilation with bag and mask or Neopuff will be required.
Mechanical ventilation should commence if the patient meets one of the following criteria after additional dose of surfactant: pCO2 \> 65 mmHg and pH \<7.20, or paO2 \<50 mm Hg, or FiO2 \>0.40 after surfactant administration or in case of apnea (\> 4 episodes in 1 hour or \> 2 episodes in 1 hour ventilation with bag and mask or Neopuff ), and should continue with the aim of maintaining a pCO2 of 55-65 mmHg and a SpO2 of 90-95%, using synchronized Mechanical Ventilation (MV), volume controlled MV, or high frequency ventilation.
Patients will be extubated as per center protocol.
This study, in addition to investigating the decision-making role of LUS in the administration of surfactant, also aims to evaluate the possibility of making treatment with surfactant earlier and more timely, having already been shown in the past that an early administration improves clinical outcomes.
Aim of the study The investigators hypothesized that the use of a LUS 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 (CG), and one will be managed deciding surfactant treatment using a LUS cut-off and FiO2 (LUSG).
Study design The study will be a multicenter randomized open control trial carried out in Level III-IV neonatal intensive care units (NICUs). The financial outcome of the study is no profit. The design of the study is of superiority. The enrollment period will be 24 months (starting February 1, 2022).
Study population The study will take place within the NICUs and therefore in a hospital setting. The study will be multicenter.
The total number of enrolled infants will be 668 (334 per arm). Each center will have to enroll a minimum of 10 children and a maximum of 70.
An interim analysis will be conducted after 167 infants enrolled in each arm (334 total infants enrolled).
Management in the delivery room and in the first hour of life Positive pressure with a neonatal mask and a T-piece system (Neopuff Infant Resuscitator ®, Fisher and Paykel, Auckland, New Zealand) will be used to stabilize the newborns after birth as per routine daily practice. If necessary, infants will start mechanical ventilation in agreement with the European guidelines on neonatal resuscitation. In this latter case the babies will be excluded from the study (see Exclusion criteria section).
In order to better standardize the timing of care after birth, it is expected that assistance in the delivery room, transfer of the newborn to the intensive care unit, stabilization of the newborn and the related procedures (positioning of the vascular access, stabilization of ventilatory parameters, thermal stabilization, etc.) are completed within the first hour of life.
Once infants with RDS have been screened, enrolled in the study, and allocated to the CG or LUSG, LU will be performed as soon as possible between 1 and 3 hours life (\<3 h of life). In the meantime, the newborns will be assisted in noninvasive ventilation (nCPAP, pressure 6-8 cmH20) and oxygen to maintain preductal oxygen saturation (SpO2) between 90 and 95%. A loading dose of caffeine citrate of 20 mg/kg will be administered in the first hours of life followed by a maintenance of 5 mg/kg/day, as per routine clinical practice.
Noninvasive ventilation management after the first 3 hours of life or after surfactant administration After the first three hours of life or after having administered surfactant, according to the criteria provided by the randomization group, the newborns can be assisted with non-invasive ventilation other than nCPAP (NIPPV, BiPAP, HFNC) according to the care protocol of the centers involved in the study.
Lung ultrasound procedure LU will be performed by the attending physician. Centers participating to the study should be routinely using LU and all the physician are already trained for the use of the technique.
LUS will be calculated by performing longitudinal scans of the chest in the anterior (midclavicular line), lateral (anterior axillary line) and posterior (posterior axillary line) area bilaterally using high-frequency linear or micro linear (hockey stick) probe between 1 and 3 hour of life. The focus will be located at the level of the pleural line. A score from 0 to 3 will be assigned to each scan area based on the ultrasound detected pattern (in case of different score pattern in the same area the worst will be the one chosen).
LU can be performed keeping the patient in the supine position without the need to rotate him as the posterior axillary line is accessible from the side of the newborn.
Surfactant replacement therapy should be given if LUS is 9 or more in the babies recruited to the LUSG.
The LUS group will receive as rescue therapy surfactant administration in case of LUS \< or = 8 but FiO2\> 0.30 on nCPAP (pressure 6-8 cmH20) to maintain preductal SpO2 between 90 and 95%.
Surfactant treatment Once criteria for surfactant administration have been reached, surfactant (Curosurf ®, Chiesi, Parma, Italy) will be given (200 mg/kg) according to the InSURE (Intubate-SURfactant-Extubate), LISA (Less- Invasive-Surfactant-Administration) or IN-REC-SURE (INtubate-RECruit-SURfactant-Extubate) technique in both the groups as per the enrollment center protocol.
Pharmacological premedication with fentanest and/or atropine will be allowed (as per center protocol) and recorded.
After surfactant administration, the babies of both groups will be extubated if it has been performed the InSURE or IN-REC-SURE method within 30 min (if satisfactory respiratory drive is present) and will receive nCPAP (pressure 6-8 cmH2O) as per center protocol .
Infants of both groups can receive a subsequent dose of surfactant (100 mg/kg of poractant alfa) using the same method if they meet the non-invasive ventilation failure criteria again during the following 12 to 24 h.
nCPAP ventilation failure criteria In the NICU, nCPAP will be the standard method of noninvasive support in all infants recruited to this trial. nCPAP failure is defined if any of the following criteria are met: FiO2 ≥ 0.30 to maintain a SpO2\> 90 for at least 30 min unless rapid clinical deterioration has occurred; respiratory acidosis defined as pCO2 \> 65 mmHg (8.5 kPa) and pH \<7.20 on an arterial or capillary blood gas sample; apnea defined as more than four episodes of apnea per hour or more than two episodes of apnea per hour when ventilation with bag and mask or Neopuff will be required.
Mechanical ventilation should commence if the patient meets one of the following criteria after additional dose of surfactant: pCO2 \> 65 mmHg and pH \<7.20, or paO2 \<50 mm Hg, or FiO2 \>0.40 after surfactant administration or in case of apnea (\> 4 episodes in 1 hour or \> 2 episodes in 1 hour ventilation with bag and mask or Neopuff ), and should continue with the aim of maintaining a pCO2 of 55-65 mmHg and a SpO2 of 90-95%, using synchronized Mechanical Ventilation (MV), volume controlled MV, or high frequency ventilation.
Patients will be extubated as per center protocol.
Conditions
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Respiratory Distress Syndrome, Newborn
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Control group (CG)
decision to administer exogenous surfactant when FiO2 \>0.30 on nCPAP (pressure 6-8 cmH20) to maintain preductal SpO2 between 90 and 95%.
Group Type
ACTIVE_COMPARATOR
Lung ultrasound score (LUS)
Intervention Type
DIAGNOSTIC_TEST
LU score (LUS) will be performed between 1 and 3 hours of life. LUS will be calculated by performing longitudinal scans of the chest in the anterior (midclavicular line), lateral (anterior axillary line) and posterior (posterior axillary line) area bilaterally using high-frequency linear or micro linear (hockey stick) probe. A score from 0 to 3 will be assigned to each area based on the ultrasound detected pattern.
LUS group (LUSG)
decision to administer surfactant when LUS \> 8 on nCPAP (pressure 6-8 cmH20) to maintain preductal SpO2 between 90 and 95%.
The LUS group will receive surfactant administration as rescue therapy in case of LUS \< or = 8 but FiO2 \> 0.30 on nCPAP (pressure 6-8 cmH20) to maintain preductal SpO2 between 90 and 95%.
Group Type
EXPERIMENTAL
Lung ultrasound score (LUS)
Intervention Type
DIAGNOSTIC_TEST
LU score (LUS) will be performed between 1 and 3 hours of life. LUS will be calculated by performing longitudinal scans of the chest in the anterior (midclavicular line), lateral (anterior axillary line) and posterior (posterior axillary line) area bilaterally using high-frequency linear or micro linear (hockey stick) probe. A score from 0 to 3 will be assigned to each area based on the ultrasound detected pattern.
Interventions
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Lung ultrasound score (LUS)
LU score (LUS) will be performed between 1 and 3 hours of life. LUS will be calculated by performing longitudinal scans of the chest in the anterior (midclavicular line), lateral (anterior axillary line) and posterior (posterior axillary line) area bilaterally using high-frequency linear or micro linear (hockey stick) probe. A score from 0 to 3 will be assigned to each area based on the ultrasound detected pattern.
Intervention Type
DIAGNOSTIC_TEST
Eligibility Criteria
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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
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
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
Minimum Eligible Age
1 Minute
Maximum Eligible Age
3 Hours
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Azienda Ospedaliero-Universitaria Careggi
OTHER
Sponsor Role
lead
Responsible Party
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Iuri Corsini
Neonatologist at the Careggi University Hospital NICU
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Iuri Corsini, MD
Role: PRINCIPAL_INVESTIGATOR
Careggi University Hospital of Florence
Locations
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Neonatal intensive care unit - Azienda Sanitaria dell'Alto Adige
Bolzano, , Italy
Site Status
Spedali Civili di Brescia
Brescia, , Italy
Site Status
AOU Careggi
Florence, , Italy
Site Status
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano
Milan, , Italy
Site Status
Neonatal Intensive Care Unit Ospedale dei Bambini "Vittore Buzzi"
Milan, , Italy
Site Status
Neonatal Intensive Care Unit Modena
Modena, , Italy
Site Status
Neonatal Intensive Care Unit - Federico II University
Napoli, , Italy
Site Status
Azienda Ospedaliero-Universitaria Pisana
Pisa, , Italy
Site Status
Neonatologia e Terapia Intensiva Neonatale Rimini
Rimini, , Italy
Site Status
Fondazione Policlinico Gemelli
Roma, , Italy
Site Status
Azienda sanitaria universitaria Friuli Centrale
Udine, , Italy
Site Status
NICU AOUI Verona
Verona, , Italy
Site Status
Germans Trias i Pujol
Badalona, Spain, Spain
Site Status
Neonatal Intensive Care Unit Coruña
A Coruña, , Spain
Site Status
Barcelona Center for Maternal Fetal and Neonatal Medicine
Barcelona, , Spain
Site Status
Neonatal Intensive Care Unit, Puerta del Mar Universitary Hospital, Cádiz.
Cadiz, , Spain
Site Status
Hospital Gregorio Maranon
Madrid, , Spain
Site Status
Hospital Alvaro Cunqueiro de Vigo. Instituto de Investigación Galicia Sur
Vigo, , Spain
Site Status
Countries
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Italy
Spain
References
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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. Neonatology. 2019;115(4):432-450. doi: 10.1159/000499361. Epub 2019 Apr 11.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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. doi: 10.1016/j.jpeds.2019.04.020. Epub 2019 May 10.
Reference Type
BACKGROUND
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. doi: 10.1007/s00431-020-03744-y. Epub 2020 Jul 24.
Reference Type
BACKGROUND
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/jamapediatrics.2015.1797. Epub 2015 Aug 3.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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 description of a new entity. Lancet Respir Med. 2017 Aug;5(8):657-666. doi: 10.1016/S2213-2600(17)30214-X. Epub 2017 Jul 4.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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 at birth. Resuscitation. 2021 Apr;161:291-326. doi: 10.1016/j.resuscitation.2021.02.014. Epub 2021 Mar 24.
Reference Type
BACKGROUND
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 Administration: A Pragmatic, Multicenter Study. Chest. 2021 Dec;160(6):2178-2186. doi: 10.1016/j.chest.2021.06.076. Epub 2021 Jul 19.
Reference Type
BACKGROUND
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 Respiratory Distress Syndrome. Pediatrics. 2021 Apr;147(4):e2020030528. doi: 10.1542/peds.2020-030528. Epub 2021 Mar 9.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Corsini I, Rodriguez-Fanjul J, Raimondi F, Boni L, Berardi A, Aldecoa-Bilbao V, Alonso-Ojembarrena A, Ancora G, Aversa S, Beghini R, Meseguer NB, Capasso L, Chesi F, Ciarcia M, Concheiro A, Corvaglia L, Ficial B, Filippi L, Carballal JF, Fusco M, Gatto S, Ginovart G, Gregorio-Hernandez R, Lista G, Sanchez-Luna M, Martini S, Massenzi L, Miselli F, Mercadante D, Mosca F, Palacio MT, Perri A, Piano F, Prieto MP, Fernandez LR, Risso FM, Savoia M, Staffler A, Vento G, Dani C. Lung UltrasouNd Guided surfactant therapy in preterm infants: an international multicenter randomized control trial (LUNG study). Trials. 2023 Nov 4;24(1):706. doi: 10.1186/s13063-023-07745-8.
Reference Type
DERIVED
Other Identifiers
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302/2021
Identifier Type: -
Identifier Source: org_study_id
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ENROLLING_BY_INVITATION
Role of Lung Ultrasound In Assessment Of Recruitment Maneuvers In Ventilated Preterms With Respiratory Distress Syndrome and Its Correlation With Tracheal IL-6 Level
NCT04107090
COMPLETED
NA
Bedside Ultrasound to Monitor Lung Function and Blood Flow in Newborns Treated With Surfactant
NCT07070167
NOT_YET_RECRUITING
A Multicenter, Randomized, Open Label Trial of a New Animal Extracted Surfactant to Treat RDS in Preterm Infants
NCT02305160
COMPLETED
PHASE2/PHASE3
Lung Ultrasound for Prediction of Bronchopulmonary Dysplasia
NCT04756297
COMPLETED
Predictive Value of Lung Ultrasound for Respiratory Decompensation in Late Preterm Neonates
NCT07216053
RECRUITING
Lung Ultrasound and Alveolar Recruitment in Mechanically Ventilated Infants
NCT02584023
COMPLETED
NA
Neonatologist-performed Lung Ultrasound in the Delivery Room
NCT06408480
RECRUITING
The Effect of Surfactant Dose on Outcomes in Preterm Infants With RDS
NCT03808402
COMPLETED
Efficacy of a New Technique -"IN-REC-SUR-E"- in Preterm Neonates With RDS
NCT02482766
COMPLETED
NA
Cerebral and Renal Oximetry Study in Preterm Patients Who Require Surfactant Administration
NCT05091840
UNKNOWN
Combined Lung Ultrasounds and Transthoracic Electrical Bioimpedance in Preterm Infants With Respiratory Distress.
NCT04359134
UNKNOWN
Lung Ultrasound - Prospective Study
NCT06140615
RECRUITING
NA
The Use of Lung Ultrasonography in the Delivery Room in Neonates
NCT06314789
ENROLLING_BY_INVITATION
NA
Surfactant Versus Nasal Continuous Positive Airway Pressure (nCPAP) for Respiratory Distress Syndrome in the Newborn ≥ 35 Weeks of Gestation
NCT01306240
TERMINATED
PHASE3
The Baby Lung Study
NCT05152316
COMPLETED
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
NCT05791331
NOT_YET_RECRUITING
NA
Lung Ultrasound in Neonatal Intensive Care Units
NCT06372951
NOT_YET_RECRUITING
Lung Ultrasound to Diagnose Transient Tachypnea of the Newborn (TTN) Versus Respiratory Distress Syndrome (RDS) in Neonates
NCT01517958
COMPLETED
Two Strategies of RDS Treatment in Newborns With Birth Weight > 1500 Grams
NCT00277030
UNKNOWN
PHASE4