Trial reportArchives of disease in childhood. Fetal and neonatal edition2017
A first-in-human clinical study of a new SP-B and SP-C enriched synthetic surfactant (CHF5633) in preterm babies with respiratory distress syndrome.
Trial report in Archives of disease in childhood. Fetal and neonatal edition, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01651637 (A First in Human Clinical Study on the Safety and Tolerability of Two Escalating Single Doses of CHF 5633), which is not on this map. Cited by 24 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A First in Human Clinical Study on the Safety and Tolerability of Two Escalating Single Doses of CHF 5633 (Synthetic Surfactant) in Preterm Neonates With Respiratory Distress Syndrome
Who cites it
24 citing papers in PubMed, 1 synthesis or guideline pooled it, 71 citations in OpenAlex.
- European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2019 Update.Neonatology · 2019Guideline
- Surfactant therapy in neonatal care: advances, challenges, and practical considerations.European journal of pediatrics · 2026Review
- Surfactant therapy for the treatment of acute respiratory distress syndrome: time to revisit?Journal of applied physiology (Bethesda, Md. : 1985) · 2026Review
- Effect of photobiomodulation therapy on surfactant production increase in human lung epithelial alveolar cells.Photochemical & photobiological sciences : Official journal of the European Photochemistry Association and the European Society for Photobiology · 2025Article
- Moving on from clinical animal-derived surfactants to peptide-based synthetic pulmonary surfactant.American journal of physiology. Lung cellular and molecular physiology · 2024Review
- What is new in synthetic lung surfactant protein technology?Expert review of respiratory medicine · 2024Article
- Lung surfactant as a biophysical assay for inhalation toxicology.Current research in toxicology · 2023Review
- Efficacy, dose-response, and aerosol delivery of dry powder synthetic lung surfactant treatment in surfactant-deficient rabbits and premature lambs.Respiratory research · 2022Article
- Aerosol Delivery of Lung Surfactant and Nasal CPAP in the Treatment of Neonatal Respiratory Distress Syndrome.Frontiers in pediatrics · 2022Review
- Management Practices During Perinatal Respiratory Transition of Very Premature Infants.Frontiers in pediatrics · 2022Review
- Exogenous pulmonary surfactant: A review focused on adjunctive therapy for severe acute respiratory syndrome coronavirus 2 including SP-A and SP-D as added clinical marker.Current opinion in colloid & interface science · 2021Review
- Impact of synthetic surfactant CHF5633 with SP-B and SP-C analogues on lung function and inflammation in rabbit model of acute respiratory distress syndrome.Physiological reports · 2021Article
- Pulmonary Surfactants: a New Therapeutic Target in Asthma.Current allergy and asthma reports · 2020Review
- Surfactant replacement therapy: from biological basis to current clinical practice.Pediatric research · 2020Review
- Delivery room handling of the newborn.Journal of perinatal medicine · 2019Review
- Mass spectrometry imaging as a tool for evaluating the pulmonary distribution of exogenous surfactant in premature lambs.Respiratory research · 2019Article
- Why, when, and how to give surfactant.Pediatric research · 2019Article
- Surfactant preparations for preterm infants with respiratory distress syndrome: past, present, and future.Korean journal of pediatrics · 2019Review
- Efficient delipidation of a recombinant lung surfactant lipopeptide analogue by liquid-gel chromatography.PloS one · 2019Article
- Metabolism of a synthetic compared with a natural therapeutic pulmonary surfactant in adult mice.Journal of lipid research · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 10 institutions in 9 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveCHF5633 (Chiesi Farmaceutici S.p.A., Parma, Italy) is the first fully synthetic surfactant enriched by peptide analogues of
designMulticentre cohort study. PATIENTS: Forty infants from 27 OUTCOME MEASURES: Adverse events (AEs) and adverse drug reactions (ADRs) were monitored with complications of prematurity considered AEs if occurring after dosing. Systemic absorption and immunogenicity were assessed. Efficacy was assessed by change in FiO
resultsRapid and sustained improvements in FiO
conclusionsBoth CHF5633 doses were well tolerated and showed promising clinical efficacy profile. These encouraging data provide a basis for ongoing randomised controlled trials. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT01651637.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.