The Randomized, Controlled Trial of Late Surfactant: Effects on Respiratory Outcomes at 1-Year Corrected Age

TOLSURF Study Group

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

Objective 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). Study design 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). Results 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. Conclusion 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. Trial registration ClinicalTrials.gov: NCT01022580

Original languageEnglish (US)
Pages (from-to)19-25.e2
JournalJournal of Pediatrics
Volume183
DOIs
StatePublished - Apr 1 2017
Externally publishedYes

Fingerprint

Surface-Active Agents
Randomized Controlled Trials
Gestational Age
Nitric Oxide
Newborn Infant
Morbidity
Lung
Caregivers
Hospitalization
Parturition
Pregnancy
Control Groups
Therapeutics

Keywords

  • bronchopulmonary dysplasia
  • prematurity
  • pulmonary morbidity
  • wheeze

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

Cite this

The Randomized, Controlled Trial of Late Surfactant : Effects on Respiratory Outcomes at 1-Year Corrected Age. / TOLSURF Study Group.

In: Journal of Pediatrics, Vol. 183, 01.04.2017, p. 19-25.e2.

Research output: Contribution to journalArticle

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title = "The Randomized, Controlled Trial of Late Surfactant: Effects on Respiratory Outcomes at 1-Year Corrected Age",
abstract = "Objective 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). Study design 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). Results 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. Conclusion 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. Trial registration ClinicalTrials.gov: NCT01022580",
keywords = "bronchopulmonary dysplasia, prematurity, pulmonary morbidity, wheeze",
author = "{TOLSURF Study Group} and Keller, {Roberta L.} and Eichenwald, {Eric C.} and Hibbs, {Anna Maria} and Rogers, {Elizabeth E.} and Wai, {Katherine C.} and Black, {Dennis M.} and Ballard, {Philip L.} and Asselin, {Jeanette M.} and Truog, {William E.} and Merrill, {Jeffrey D.} and Mammel, {Mark C.} and Steinhorn, {Robin H} and Ryan, {Rita M.} and Durand, {David J.} and Bendel, {Catherine M.} and Bendel-Stenzel, {Ellen M.} and Courtney, {Sherry E.} and Ramasubbareddy Dhanireddy and Hudak, {Mark L.} and Koch, {Frances R.} and Mayock, {Dennis E.} and McKay, {Victor J.} and Jennifer Helderman and Porta, {Nicolas F.} and Rajan Wadhawan and Lisa Palermo and Ballard, {Roberta A.}",
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T1 - The Randomized, Controlled Trial of Late Surfactant

T2 - Effects on Respiratory Outcomes at 1-Year Corrected Age

AU - TOLSURF Study Group

AU - Keller, Roberta L.

AU - Eichenwald, Eric C.

AU - Hibbs, Anna Maria

AU - Rogers, Elizabeth E.

AU - Wai, Katherine C.

AU - Black, Dennis M.

AU - Ballard, Philip L.

AU - Asselin, Jeanette M.

AU - Truog, William E.

AU - Merrill, Jeffrey D.

AU - Mammel, Mark C.

AU - Steinhorn, Robin H

AU - Ryan, Rita M.

AU - Durand, David J.

AU - Bendel, Catherine M.

AU - Bendel-Stenzel, Ellen M.

AU - Courtney, Sherry E.

AU - Dhanireddy, Ramasubbareddy

AU - Hudak, Mark L.

AU - Koch, Frances R.

AU - Mayock, Dennis E.

AU - McKay, Victor J.

AU - Helderman, Jennifer

AU - Porta, Nicolas F.

AU - Wadhawan, Rajan

AU - Palermo, Lisa

AU - Ballard, Roberta A.

PY - 2017/4/1

Y1 - 2017/4/1

N2 - Objective 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). Study design 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). Results 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. Conclusion 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. Trial registration ClinicalTrials.gov: NCT01022580

AB - Objective 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). Study design 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). Results 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. Conclusion 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. Trial registration ClinicalTrials.gov: NCT01022580

KW - bronchopulmonary dysplasia

KW - prematurity

KW - pulmonary morbidity

KW - wheeze

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U2 - 10.1016/j.jpeds.2016.12.059

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