IMPORTANCE Although opioids are used to treat neonatal abstinence syndrome (NAS), the best pharmacologic treatment has not been established. OBJECTIVE To compare the safety and efficacy of methadone and morphine in NAS. DESIGN, SETTING, AND PARTICIPANTS In this randomized, double-blind, intention-to-treat trial, term infants from 8 US newborn units whose mothers received buprenorphine, methadone, or opioids for pain control during pregnancy were eligible. A total of 117 infants were randomized to receive methadone or morphine from February 9, 2014, to March 6, 2017. Mothers who declined randomization could consent to data collection and standard institutional treatment. INTERVENTIONS Infants were assessed with the Finnegan Neonatal Abstinence Scoring System every 4 hours and treated with methadone or placebo every 4 hours or morphine every 4 hours. Infants with persistently elevated Finnegan scores received dose increases. Infants who exceeded a predetermined opioid dose received phenobarbital. Dose reductions occurred every 12 to 48 hours when signs of NAS were controlled with therapy, stopping at 20% of the original dose. MAIN OUTCOMES AND MEASURES The primary end point was length of hospital stay (LOS). The secondary end points were LOS attributable to NAS and length of drug treatment (LOT). RESULTS A total of 183 mothers consented to have their infants in the study; 117 infants required treatment. Because 1 parent withdrew consent, data were analyzed on 116 infants (mean [SD] gestational age, 39.1 [1.1] weeks; mean [SD] birth weight, 3157 [486] g; 58 [50%] male). Demographic variables and risk factors were similar except for more prenatal cigarette exposure in infants who received methadone. Adjusting for study site and maternal opioid type, methadone was associated with decreased mean number of days for LOS by 14%
Co-inheritance of a-thalassemia dramatically decreases the risk of acute splenic sequestration in a large cohort of newborns with hemoglobin SC Hemoglobin SC (HbSC) is the second most common variant of sickle cell disease worldwide after Hb SS. Hb C is caused by a mutation in the seventh codon of the HBB gene [HBB:c.19G>A(p.Glu7Lys)]. The β S allele is associated with different β S haplotypes that are named according to the region in which they originated, 1 although such multicentric origin of the β S allele has recently been proven to be unreliable. 2 In addition to this anthropological importance, different β S haplotypes can modulate the severity of sickle cell anemia. 3 β C haplotypes I, II, and III were first described by Boehm et al. 4 There are no data in the literature on the association of β C haplotypes with clinical and hematologic features. Likewise, the effect of co-inheritance of a-thalassemia (a-thal) in patients with HbSC is still unclear.This study was based on a retrospective cohort of 461 newborns from Minas Gerais, Brazil (birth date: 01/01/1999 to 31/12/2012). Results on the clinical and hematologic profiles have been recently published. 5 Methods for the determination of a-thal and β-globin gene cluster haplotypes, as well as detailed statistical methods are available in the Online Supplementary Appendix S1. P<0.01 was considered significant. The study was approved by the institutional research ethics committee (protocol 13327713.5.0000.5149).Co-inheritance of a-thal was determined in 389 children; 77 (19.8%) were -a 3.7 /aa and one (0.26%) -a 3.7 /-a 3.7 ; 311 (79.9%) had wild HBA alleles (aa/aa). The patients were analyzed for a follow up of a total of 3,522.72 patient-years. There was no difference in follow up between the two groups (8.78 and 9.13 years for patients with or without co-inheritance of a-thal, respectively; P=0.51). The incidence of pain crises for all those 389 children was 52.1 episodes per 100 patient-years (95%CI: 49.8-54.6). The incidence of infections was 60.1 events per 100 patient-years (95%CI: 57.6-62.7), and that of red blood cell (RBC) transfusions, 4.4 events per 100 patient-years (95%CI: 3.73-5.15).The risks of pain crises, infections, and RBC transfu-
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