Inhaled nitric oxide therapy improves the pulmonary outcome for premature infants who are at risk for bronchopulmonary dysplasia when it is started between 7 and 21 days of age and has no apparent short-term adverse effects. (ClinicalTrials.gov number, NCT00000548 [ClinicalTrials.gov] .).

Objective-To identify whether inhaled nitric oxide treatment decreased indicators of long-term pulmonary morbidities after discharge from the NICU.Study design-The NO CLD trial enrolled preterm infants (<1250g) between 7-21 days of age who were ventilated and at high risk for BPD. Follow-up occurred at 12 ± 3 months of age adjusted for prematurity; long-term pulmonary morbidities and other outcomes were reported by parents during structured blinded interviews.

Objective-In a randomized multi-center trial, we demonstrated that inhaled nitric oxide begun between 7 and 21 days and treated for 24 days significantly increased survival without bronchopulmonary dysplasia (BPD) in ventilated premature infants weighing < 1250 g. Since some preventative BPD treatments are associated with neurodevelopmental impairment, we designed a follow-up study to assess the safety of nitric oxide.Study design-Our hypothesis was that inhaled nitric oxide will not increase neurodevelopmental impairment compared with placebo. We prospectively evaluated neurodevelopmental and growth outcomes at 24 months PMA in 477 (89%) of 535 surviving infants enrolled in the trial.Results-In the treated group, 109 of 243 children (45%) had neurodevelopmental impairment (moderate or severe cerebral palsy, bilateral blindness, bilateral hearing loss or score of less than 70 on the Bayley Scales II), compared with 114 of 234 (49%) in the placebo group (Relative Risk 0.92; 95% confidence interval, 0.75 to 1.12; p = 0.39). No differences on any subcomponent of neurodevelopmental impairment or growth variables were found between inhaled nitric oxide or placebo.Conclusions-Inhaled nitric oxide improved survival free of bronchopulmonary dysplasia with no adverse neurodevelopmental effects at 2 years of age.Advances in neonatal-perinatal medicine have resulted in increased survival rates among premature infants. However, morbidities of prematurity, including bronchopulmonary dysplasia, a major contributor to neurodevelopmental impairment, have not decreased. In a single center controlled trial of inhaled nitric oxide in preterm infants Schreiber et al 1 showed Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.The authors declare no other conflicts of interest.Registered at ClinicalTrials.gov (NCT00000548). In the multicenter NO CLD Trial we demonstrated that inhaled nitric oxide significantly increased survival without bronchopulmonary dysplasia as determined at 36 weeks' postmenstrual age in premature infants weighing less than 1250 g requiring ventilatory support between 7 and 21 days of life. 7, 8 Treated infants were more likely to be discharged or off respiratory support at 40 weeks postmenstrual age7, required fewer days of ventilatory support and hospitalization9, and were less likely to require treatment with pulmonary medications in the first year. 10 In post hoc analyses infants entered between 7-14 days of age, compared with those enrolled later, had greater benefit (P=0.005), and non-white infants appeared to respond better than white infants (Interaction P=0....

Despite its higher price relative to many other neonatal therapies, iNO in this trial was not associated with higher costs of care, an effect that is likely due to its impact on length of stay and ventilation. Indeed, for infants who receive nitric oxide between 7 and 14 days of life, the therapy seemed to lower costs while improving outcomes.

OBJECTIVE: In 2009, the National Children's Study (NCS) Vanguard Study tested the feasibility of household-based recruitment and participant enrollment using a birth-rate probability sample. In 2010, the NCS Program Office launched 3 additional recruitment approaches. We tested whether provider-based recruitment could improve recruitment outcomes compared with household-based recruitment. METHODS:The NCS aimed to recruit 18-to 49-year-old women who were pregnant or at risk for becoming pregnant who lived in designated geographic segments within primary sampling units, generally counties. Using provider-based recruitment, 10 study centers engaged providers to enroll eligible participants at their practice. Recruitment models used different levels of provider engagement (full, intermediate, information-only). RESULTS:The percentage of eligible women per county ranged from 1.5% to 57.3%. Across the centers, 3371 potential participants were approached for screening, 3459 (92%) were screened and 1479 were eligible (43%). Of those 1181 (80.0%) gave consent and 1008 (94%) were retained until delivery. Recruited participants were generally representative of the county population. CONCLUSIONS:Provider-based recruitment was successful in recruiting NCS participants. Challenges included time-intensity of engaging the clinical practices, differential willingness of providers to participate, and necessary reliance on providers for participant identification. The vast majority of practices cooperated to some degree. Recruitment from obstetric practices is an effective means of obtaining a representative sample.