Target Oxygen Ranges in Infants With Pulmonary Hypertension
Conditions: Bronchopulmonary Dysplasia; Pulmonary Hypertension Interventions: Device: higher oxygen saturation target using Nellcor pulse oximetry sensors; Device: lower oxygen saturation target using Nellcor pulse oximetry sensors Sponsors: University of Alabama at Birmingham Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - April 18, 2024 Category: Research Source Type: clinical trials

Does the use of higher versus lower oxygen concentration improve neurodevelopmental outcomes at 18 –24 months in very low birthweight infants?
DiscussionThe use of supplementary oxygen may be crucial but also potentially detrimental to preterm infants at birth. The HiLo trial is powered for the primary outcome and will address gaps in the evidence due to its pragmatic and inclusive design, targeting all extremely preterm infants. Should 60% initial oxygen concertation increase survival free of major neurodevelopmental outcomes at 18 –24 months corrected age, without severe adverse effects, this readily available intervention could be introduced immediately into clinical practice.Trial registrationThe trial was registered on January 31, 2019, at ClinicalTrials....
Source: Trials - April 4, 2024 Category: Research Source Type: clinical trials

The Role of VOCs, Airway Mucins and Airway Microbiome in Bronchopulmonary Dysplasia
Conditions: Bronchopulmonary Dysplasia Interventions: Diagnostic Test: Breath test; Other: Throat swabs; Other: Placental samples; Other: Vaginal swab; Other: Endotracheal aspirates Sponsors: University Hospital, Antwerp Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - April 2, 2024 Category: Research Source Type: clinical trials

The Diaphragmatic Initiated Ventilatory Assist (DIVA) trial: study protocol for a randomized controlled trial comparing rates of extubation failure in extremely premature infants undergoing extubation to non-invasive neurally adjusted ventilatory assist versus non-synchronized nasal intermittent positive pressure ventilation
DiscussionThe DIVA trial is the first large multicenter trial designed to assess the impact of NIV-NAVA on relevant clinical outcomes for preterm infants. The DIVA trial design incorporates input from clinical NAVA experts and includes innovative features, such as a run-in phase, to ensure consistent technical performance across sites.Trial registrationwww.ClinicalTrials.gov, trial identifierNCT05446272, registered July 6, 2022. (Source: Trials)
Source: Trials - March 20, 2024 Category: Research Source Type: clinical trials

Safety and Efficacy of MSC-EVs in the Prevention of BPD in Extremely Preterm Infants
Conditions: Bronchopulmonary Dysplasia Interventions: Biological: Endotracheopulmonary Instillation, Suspension Sponsors: EXO Biologics S.A. Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - February 28, 2024 Category: Research Source Type: clinical trials

Use of Mesenchymal Stem Cells in Pre-term Patients With Bronchopulmonary Dysplasia.
Conditions: Bronchopulmonary Dysplasia Interventions: Biological: Control; Biological: Allogenic fetal mesenchymal stem cells from umbilical cord - three infusions; Biological: Allogenic fetal mesenchymal stem cells from umbilical cord - six infusions Sponsors: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - February 21, 2024 Category: Research Source Type: clinical trials

Detailed statistical analysis plan for a secondary Bayesian analysis of the SafeBoosC-III trial: a multinational, randomised clinical trial assessing treatment guided by cerebral oximetry monitoring versus usual care in extremely preterm infants
DiscussionThis statistical analysis plan presents a secondary Bayesian analysis of the SafeBoosC-III trial. The analysis and the final manuscript will be carried out and written after we publicise the primary frequentist trial report. Thus, we can interpret the findings from both the frequentists and Bayesian perspective. This approach should provide a better foundation for interpreting of our findings.Trial registrationClinicalTrials.org, NCT03770741. Registered on 10 December 2018. (Source: Trials)
Source: Trials - November 16, 2023 Category: Research Source Type: clinical trials

Intratracheal budesonide mixed with surfactant to increase survival free of bronchopulmonary dysplasia in extremely preterm infants: statistical analysis plan for the international, multicenter, randomized PLUSS trial
AbstractBackgroundBronchopulmonary dysplasia (BPD), an inflammatory-mediated chronic lung disease, is common in extremely preterm infants born before 28  weeks’ gestation and is associated with an increased risk of adverse neurodevelopmental and respiratory outcomes in childhood. Effective and safe prophylactic therapies for BPD are urgently required. Systemic corticosteroids reduce rates of BPD in the short term but are associated with poorer ne urodevelopmental outcomes if given to ventilated infants in the first week after birth. Intratracheal administration of corticosteroid admixed with exogenous surfactant could o...
Source: Trials - November 6, 2023 Category: Research Source Type: clinical trials

Lung UltrasouNd Guided surfactant therapy in preterm infants: an international multicenter randomized control trial (LUNG study)
In this study, 668 spontaneously-breathing preterm infants, born at 25+0 to 29+6 weeks’ gestation, in nasal continuous positive airway pressure (nCPAP) will be randomized to receive SRT only when the FiO2 cut-off exceeds 0.3 (control group) or if the LUS score is higher than 8 or the FiO2 requirements exceed 0.3 (study group) (334 infants per arm). The primary outcome will be the difference in proportion of infants with BPD or death in the study group managed compared to the control group.DiscussionBased on previous published studies, it seems that LUS may decrease the time to administer surfactant therapy. It is known...
Source: Trials - November 4, 2023 Category: Research Source Type: clinical trials

Reversibility of Bronchial Obstruction in Children Born Preterm
Conditions: Bronchopulmonary Dysplasia; Chronic Lung Disease of Prematurity; Chronic Lung Disease of Newborn; Preterm Birth Complication; Bronchial Hyperreactivity; Bronchial Obstruction; Reversible Dilatation Sponsors: Charles University, Czech Republic Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - October 31, 2023 Category: Research Source Type: clinical trials

Systemic Management in Extremely Preterm and Extremely Low Birth Weight Infants
Conditions: Bronchopulmonary Dysplasia; Death Interventions: Other: no interventions Sponsors: Peking University; Peking University First Hospital; Peking University People ' s Hospital; Peking University Third Hospital; Tianjin Central Hospital of Gynecology Obstetrics; Peking Union Medical College Hospital; Beijing Children ' s Hospital; Beijing Friendship Hospital; Shanxi Provincial Maternity and Children ' s Hospital; The Second Hospital of Hebei Medical University; Handan Central Hospital; Xingtai People ' s Hospital; Tianjin Medical University General Hospital; The Affiliated Hospital of Inner Mongolia Medical Univer...
Source: ClinicalTrials.gov - October 13, 2023 Category: Research Source Type: clinical trials

Doxapram versus placebo in preterm newborns: a study protocol for an international double blinded multicentre randomized controlled trial (DOXA-trial)
DiscussionDoxapram has the potential to improve neonatal outcomes by improving respiration, but the safety concerns need to be weighed against the potential risks of invasive mechanical ventilation. It is unknown if the use of doxapram improves the long-term outcome. This forms the clinical equipoise of the current trial. This international, multicentre trial will provide the needed high-quality evidence on the efficacy and safety of doxapram in the treatment of AOP in preterm infants.Trial registrationClinicalTrials.gov NCT04430790 and EUDRACT 2019-003666-41. Prospectively registered on respectively June and January 2020. (Source: Trials)
Source: Trials - October 10, 2023 Category: Research Source Type: clinical trials

High-flow nasal cannula (HFNC) vs continuous positive airway pressure (CPAP) vs nasal intermittent positive pressure ventilation as primary respiratory support in infants of  ≥ 32 weeks gestational age (GA): study protocol for a three-arm multi-center randomized controlled trial
This study will provide clinical evidence for the development of respiratory treatment strategies in neonates at GA ≥ 32 weeks with RD, with the aim of minimizing the incidence of tracheal intubation and reducing the complications associated with NIV.Trial registrationChinese Clinical Trial Registry: ChiCTR2300069192. Registered on March 9, 2023,https://www.chictr.org.cn/showproj.html?proj=171491. (Source: Trials)
Source: Trials - October 6, 2023 Category: Research Source Type: clinical trials

Early-life MRI Biomarkers of Longer-term Respiratory Morbidity in Infants Born Extremely Preterm (EMBLEM)
Conditions: Lung Function; BPD - Bronchopulmonary Dysplasia Interventions: Diagnostic Test: Magnetic Resonance Imaging (MRI); Diagnostic Test: Echocardiogram; Diagnostic Test: Lung ultrasound Sponsors: Children ' s Hospital of Eastern Ontario; The Hospital for Sick Children; MOUNT SINAI HOSPITAL; Hannover Medical School; St. Justine ' s Hospital; Montreal Children ' s Hospital of the MUHC Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - October 3, 2023 Category: Research Source Type: clinical trials

PUFAs in Preterm Infants
Conditions: Necrotizing Enterocolitis; Intraventricular Hemorrhage; BPD - Bronchopulmonary Dysplasia; Sepsis; Periventricular Leukomalacia; Patent Ductus Arteriosus Sponsors: The First Hospital of Jilin University Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - September 21, 2023 Category: Research Source Type: clinical trials