Trial reportPediatrics2020
Aerosolized Calfactant for Newborns With Respiratory Distress: A Randomized Trial.
Trial report in Pediatrics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 3 of them syntheses 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
36 citing papers in PubMed, 3 syntheses or guidelines pooled it, 90 citations in OpenAlex.
- Comparative efficacy and safety of pulmonary surfactant delivery strategies in neonatal RDS: a network meta-analysis.BMC pulmonary medicine · 2024Pooled it
- Eligible Infants Included in Neonatal Clinical Trials and Reasons for Noninclusion: A Systematic Review.JAMA network open · 2024Pooled it
- Race and Ethnicity of Infants Enrolled in Neonatal Clinical Trials: A Systematic Review.JAMA network open · 2023Pooled it
- High vs low CPAP strategy with aerosolized calfactant in preterm infants with respiratory distress syndrome.Journal of perinatology : official journal of the California Perinatal Association · 2025Trial
- Response to aerosolized calfactant in infants with respiratory distress syndrome; a post-hoc analysis of AERO-02 trial.Journal of perinatology : official journal of the California Perinatal Association · 2023Trial
- [A multicenter study on vibrating mesh nebulization of pulmonary surfactant for treating respiratory distress syndrome in preterm infants].Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2026Observational
- Effects of an alkane on the adsorption and collapse by the lipids of pulmonary surfactant.Biophysical journal · 2026Article
- Impact of Newborn CCHD Screening Using Pulse Oximetry in the United States.Pediatric cardiology · 2026Article
- Non-Invasive Surfactant Administration in Preterm Infants.Children (Basel, Switzerland) · 2026Review
- Prophylactic surfactant therapy in the era of less invasive surfactant delivery.Journal of perinatology : official journal of the California Perinatal Association · 2026Review
- Preclinical Testing of a New Dry Powder Aerosol Synthetic Lung Surfactant Formulation and Device Combination for the Treatment of Neonatal Respiratory Distress Syndrome.Journal of aerosol medicine and pulmonary drug delivery · 2025Article
- Alveolar distribution of nebulized solution in health and lung injury assessed by confocal microscopy.Physiological reports · 2024Article
- Development of a New Dry Powder Aerosol Synthetic Lung Surfactant Product for Neonatal Respiratory Distress Syndrome (RDS) - Part I: In Vitro Testing and Characterization.Pharmaceutical research · 2024Article
- Less invasive surfactant administration methods: Who, what and how.Journal of perinatology : official journal of the California Perinatal Association · 2024Review
- Prophylactic Oropharyngeal Surfactant for Preterm Newborns at Birth: A Randomized Clinical Trial.JAMA pediatrics · 2024Article
- Less Invasive Surfactant Administration: A Viewpoint.American journal of perinatology · 2024Review
- A multicentre neonatal interventional randomised controlled trial of nebulized surfactant for preterm infants with respiratory distress: Neo-INSPIRe trial protocol.BMC pediatrics · 2023Article
- RDS-NExT workshop: consensus statements for the use of surfactant in preterm neonates with RDS.Journal of perinatology : official journal of the California Perinatal Association · 2023Article
- Should less invasive surfactant administration (LISA) become routine practice in US neonatal units?Pediatric research · 2023Review
- Effects of cholesterol on the structure and collapse of DPPC monolayers.Biophysical journal · 2022Article
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Authors and funding
23 authors at 19 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundExogenous surfactants to treat respiratory distress syndrome (RDS) are approved for tracheal instillation only; this requires intubation, often followed by positive pressure ventilation to promote distribution. Aerosol delivery offers a safer alternative, but clinical studies have had mixed results. We hypothesized that efficient aerosolization of a surfactant with low viscosity, early in the course of RDS, could reduce the need for intubation and instillation of liquid surfactant.
methodsA prospective, multicenter, randomized, unblinded comparison trial of aerosolized calfactant (Infasurf) in newborns with signs of RDS that required noninvasive respiratory support. Calfactant was aerosolized by using a Solarys nebulizer modified with a pacifier adapter; 6 mL/kg (210 mg phospholipid/kg body weight) were delivered directly into the mouth. Infants in the aerosol group received up to 3 treatments, at least 4 hours apart. Infants in the control group received usual care, determined by providers. Infants were intubated and given instilled surfactant for persistent or worsening respiratory distress, at their providers' discretion.
resultsAmong 22 NICUs, 457 infants were enrolled; gestation 23 to 41 (median 33) weeks and birth weight 595 to 4802 (median 1960) grams. In total, 230 infants were randomly assigned to aerosol; 225 received 334 treatments, starting at a median of 5 hours. The rates of intubation for surfactant instillation were 26% in the aerosol group and 50% in the usual care group (
conclusionsIn newborns with early, mild to moderate respiratory distress, aerosolized calfactant at a dose of 210 mg phospholipid/kg body weight reduced intubation and surfactant instillation by nearly one-half.
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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.