Elsevier

The Journal of Pediatrics

Volume 165, Issue 2, August 2014, Pages 240-249.e4
The Journal of Pediatrics

Original Article
Respiratory Outcomes of the Surfactant Positive Pressure and Oximetry Randomized Trial (SUPPORT)

https://doi.org/10.1016/j.jpeds.2014.02.054Get rights and content

Objective

To explore the early childhood pulmonary outcomes of infants who participated in the National Institute of Child Health and Human Development's Surfactant Positive Airway Pressure and Pulse Oximetry Randomized Trial (SUPPORT), using a factorial design that randomized extremely preterm infants to lower vs higher oxygen saturation targets and delivery room continuous positive airway pressure (CPAP) vs intubation/surfactant.

Study design

The Breathing Outcomes Study, a prospective secondary study to the Surfactant Positive Airway Pressure and Pulse Oximetry Randomized Trial, assessed respiratory morbidity at 6-month intervals from hospital discharge to 18-22 months corrected age (CA). Two prespecified primary outcomes—wheezing more than twice per week during the worst 2-week period and cough longer than 3 days without a cold—were compared for each randomized intervention.

Results

One or more interviews were completed for 918 of the 922 eligible infants. The incidences of wheezing and cough were 47.9% and 31.0%, respectively, and did not differ between the study arms of either randomized intervention. Infants randomized to lower vs higher oxygen saturation targets had a similar risk of death or respiratory morbidity (except for croup and treatment with oxygen or diuretics at home). Infants randomized to CPAP vs intubation/surfactant had fewer episodes of wheezing without a cold (28.9% vs 36.5%; P < .05), respiratory illnesses diagnosed by a doctor (47.7% vs 55.2%; P < .05), and physician or emergency room visits for breathing problems (68.0% vs 72.9%; P < .05) by 18-22 months CA.

Conclusion

Treatment with early CPAP rather than intubation/surfactant is associated with less respiratory morbidity by 18-22 months CA. Longitudinal assessment of pulmonary morbidity is necessary to fully evaluate the potential benefits of respiratory interventions for neonates.

Section snippets

Methods

Infants eligible for the Breathing Outcomes Study were infants enrolled in SUPPORT who survived to hospital discharge and consented for enrollment into the study. A total of 1316 infants from 20 centers across the US were enrolled into SUPPORT between February 2005 and February 2009 and seen at follow-up between 2006 and 2011. As a secondary study to SUPPORT, the Breathing Outcomes Study gained approval and began recruitment after SUPPORT began enrollment. As a result, not all SUPPORT

Results

Of the 1316 patients enrolled in SUPPORT, 922 were eligible and provided consent to participate in the Breathing Outcomes Study. The 918 patients with at least 1 completed questionnaire composed the study cohort. Follow-up rates at each time point are listed in the Figure (available at www.jpeds.com).

Among the follow-up cohort, the group randomized to lower oxygen saturation targets had fewer non-Hispanic white patients and a lower proportion of patients with BPD defined using the traditional

Discussion

We report results of the Breathing Outcomes Study, a secondary study to SUPPORT, which sought to quantify respiratory morbidity by 18-22 months CA for extremely premature children born at 24-27 weeks gestation. We found no significant differences at 18-22 months CA in the incidence of either of the 2 primary outcomes (wheezing more than twice per week during the worst 2 week period or cough lasting more than 3 days without a cold) between the lower and higher oxygen saturation target groups or

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    Supported by the National Institutes of Health, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Heart, Lung, and Blood Institute (recruitment 2004-2009; follow-up 2006-2011). T.S. was supported by the NICHD (SUPPORT Breathing Outcomes Secondary Protocol K23 HD50646). Data collected at participating sites of the NICHD Neonatal Research Network were transmitted to RTI International, the data coordinating center for the network, which stored, managed, and analyzed the data for this study. The authors declare no conflicts of interest.

    Registered with ClinicalTrials.gov: NCT00233324.

    Current affiliation: Children's Hospital at Providence, Anchorage, AK.

    A list of members of the SUPPORT Study Group of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network is available at www.jpeds.com (Appendix).

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