title: The Randomized, Controlled Trial of Late Surfactant: Effects on Respiratory Outcomes at 1-Year Corrected Age.
abstract: To determine the effects of late surfactant on respiratory outcomes determined at 1-year corrected age in the Trial of Late Surfactant (TOLSURF), which randomized newborns of extremely low gestational age (≤28 weeks' gestational age) ventilated at 7-14 days to late surfactant and inhaled nitric oxide vs inhaled nitric oxide-alone (control).
  
  
  
  Caregivers were surveyed in a double-blinded manner at 3, 6, 9, and 12 months' corrected age to collect information on respiratory resource use (infant medication use, home support, and hospitalization). Infants were classified for composite outcomes of pulmonary morbidity (no PM, determined in infants with no reported respiratory resource use) and persistent PM (determined in infants with any resource use in ≥3 surveys).
  
  
  
  Infants (n = 450, late surfactant n = 217, control n = 233) were 25.3 ± 1.2 weeks' gestation and 713 ± 164 g at birth. In the late surfactant group, fewer infants received home respiratory support than in the control group (35.8% vs 52.9%, relative benefit [RB] 1.28 [95% CI 1.07-1.55]). There was no benefit of late surfactant for No PM vs PM (RB 1.27; 95% CI 0.89-1.81) or no persistent PM vs persistent PM (RB 1.01; 95% CI 0.87-1.17). After adjustment for imbalances in baseline characteristics, relative benefit of late surfactant treatment increased: RB 1.40 (95% CI 0.89-1.80) for no PM and RB 1.24 (95% CI 1.08-1.42) for no persistent PM.
  
  
  
  Treatment of newborns of extremely low gestational age with late surfactant in combination with inhaled nitric oxide decreased use of home respiratory support and may decrease persistent pulmonary morbidity.
  
  
  
  ClinicalTrials.gov: NCT01022580.
authors.affiliation: Department of Pediatrics, University of California San Francisco, San Francisco, CA. Electronic address: kellerr@peds.ucsf.edu.
authors.forename: Roberta L
authors.initials: RL
authors.lastname: Keller
authors.affiliation: Department of Pediatrics, University of Texas, Houston, TX.
authors.forename: Eric C
authors.initials: EC
authors.lastname: Eichenwald
authors.affiliation: Department of Pediatrics, Case Western Reserve University, Cleveland, OH.
authors.forename: Anna Maria
authors.initials: AM
authors.lastname: Hibbs
authors.affiliation: Department of Pediatrics, University of California San Francisco, San Francisco, CA.
authors.forename: Elizabeth E
authors.initials: EE
authors.lastname: Rogers
authors.affiliation: University of California San Francisco School of Medicine, San Francisco, CA.
authors.forename: Katherine C
authors.initials: KC
authors.lastname: Wai
authors.affiliation: Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA.
authors.forename: Dennis M
authors.initials: DM
authors.lastname: Black
authors.affiliation: Department of Pediatrics, University of California San Francisco, San Francisco, CA.
authors.forename: Philip L
authors.initials: PL
authors.lastname: Ballard
authors.affiliation: Department of Pediatrics, Benioff Children's Hospital Oakland, Oakland, CA.
authors.forename: Jeanette M
authors.initials: JM
authors.lastname: Asselin
authors.affiliation: Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO.
authors.forename: William E
authors.initials: WE
authors.lastname: Truog
authors.affiliation: Department of Pediatrics, Benioff Children's Hospital Oakland, Oakland, CA.
authors.forename: Jeffrey D
authors.initials: JD
authors.lastname: Merrill
authors.affiliation: Department of Pediatrics, Children's Hospital and Clinics of Minnesota, St Paul and Minneapolis, MN.
authors.forename: Mark C
authors.initials: MC
authors.lastname: Mammel
authors.affiliation: Department of Pediatrics, Children's National Medical Center, Washington, DC.
authors.forename: Robin H
authors.initials: RH
authors.lastname: Steinhorn
authors.affiliation: Department of Pediatrics, Medical University of South Carolina, Charleston, SC.
authors.forename: Rita M
authors.initials: RM
authors.lastname: Ryan
authors.affiliation: Department of Pediatrics, Benioff Children's Hospital Oakland, Oakland, CA.
authors.forename: David J
authors.initials: DJ
authors.lastname: Durand
authors.affiliation: Department of Pediatrics, University of Minnesota, Minneapolis, MN.
authors.forename: Catherine M
authors.initials: CM
authors.lastname: Bendel
authors.affiliation: Department of Pediatrics, Children's Hospital and Clinics of Minnesota, St Paul and Minneapolis, MN.
authors.forename: Ellen M
authors.initials: EM
authors.lastname: Bendel-Stenzel
authors.affiliation: Department of Pediatrics, University of Arkansas for Medical Sciences, Little Rock, AR.
authors.forename: Sherry E
authors.initials: SE
authors.lastname: Courtney
authors.affiliation: Department of Pediatrics, University of Tennessee Health Science Center, Memphis, TN.
authors.forename: Ramasubbareddy
authors.initials: R
authors.lastname: Dhanireddy
authors.affiliation: Department of Pediatrics, University of Florida College of Medicine, Jacksonville, FL.
authors.forename: Mark L
authors.initials: ML
authors.lastname: Hudak
authors.affiliation: Department of Pediatrics, Medical University of South Carolina, Charleston, SC.
authors.forename: Frances R
authors.initials: FR
authors.lastname: Koch
authors.affiliation: Department of Pediatrics, University of Washington, Seattle, WA.
authors.forename: Dennis E
authors.initials: DE
authors.lastname: Mayock
authors.affiliation: Department of Pediatrics, All Children's Hospital, St. Petersburg, FL.
authors.forename: Victor J
authors.initials: VJ
authors.lastname: McKay
authors.affiliation: Department of Pediatrics, Wake Forest School of Medicine/Forsyth Medical Center, Winston-Salem, NC.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Helderman
authors.affiliation: Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, IL.
authors.forename: Nicolas F
authors.initials: NF
authors.lastname: Porta
authors.affiliation: Department of Pediatrics, Florida Hospital for Children, Orlando, FL.
authors.forename: Rajan
authors.initials: R
authors.lastname: Wadhawan
authors.affiliation: Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA.
authors.forename: Lisa
authors.initials: L
authors.lastname: Palermo
authors.affiliation: Department of Pediatrics, University of California San Francisco, San Francisco, CA.
authors.forename: Roberta A
authors.initials: RA
authors.lastname: Ballard
mesh_terms: D000280:Administration, Inhalation; D000367:Age Factors; D001997:Bronchopulmonary Dysplasia / Q000517:prevention & control; D016001:Confidence Intervals; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D005865:Gestational Age; D006801:Humans; D007223:Infant; D052577:Infant, Extremely Low Birth Weight; D007231:Infant, Newborn; D008297:Male; D009569:Nitric Oxide / Q000008:administration & dosage*; D011663:Pulmonary Surfactants / Q000008:administration & dosage*; D012121:Respiration, Artificial / Q000379:methods*; D012127:Respiratory Distress Syndrome, Newborn / Q000175:diagnosis / Q000628:therapy*; D018570:Risk Assessment; D015996:Survival Rate; D013997:Time Factors
chemical_list: D011663:Pulmonary Surfactants; D009569:Nitric Oxide
keywords: bronchopulmonary dysplasia; prematurity; pulmonary morbidity; wheeze