Kelly Burgoyne, Emma Pagnamenta, Kirstie Hartwell, Vesna Stojanovik
Protocol for a randomised controlled feasibility trial of parent-delivered early language intervention for children with Down syndrome (PACT-DS)
Pilot and feasibility studies
systematic reviews reported conflicting evidence whether macrolide antibiotics reduce rates chronic lung disease prematurity cld atrisk preterm infants born less 30 weeks gestation including colonised pulmonary ureaplasma spp since adequately powered trial lacking aimed assess macrolide azithromycin improved survival without development physiologically defined moderate severe cld preterm infants aztec multicentre doubleblind randomised placebocontrolled trial conducted 28 tertiary neonatal intensive care units uk infants eligible born less 30 weeks gestation received least 2 h either noninvasive continuous positive airway pressure humidified high flow nasal cannula therapy invasive respiratory support via endotracheal tube within 72 h birth eligible infants randomly allocated 11 ratio using random permuted blocks four receive either intravenous azithromycin 20 mgkg per day 3 days followed 10 mgkg 7 days placebo allocation stratified centre gestational age birth 28 weeks vs 28 weeks azithromycin placebo vials encased tamperevident custom cardboard cartons ensure masking clinicians parents research team primary outcome survival without development physiologically defined moderate severe cld 36 weeks postmenstrual age outcomes safety analysed intentiontotreat basis randomly allocated infants regardless postrandomisation events study registered isrcrn 11650227 closed infants recruited oct 9 2019 march 22 2022 799 531 1505 eligible infants underwent random allocation three infants withdrawn including consent use data leaving 796 infants analysis survival without moderate severe cld occurred 166 42 394 infants intervention group 179 45 402 placebo group threelevel adjusted aor 084 95 ci 055129 p043 pulmonary ureaplasma spp colonisation influence treatment effect overall seven serious adverse events reported azithromycin group five graded severe two moderate six serious adverse events reported placebo group two severe two moderate two mild assessed local principal investigators since prophylactic use azithromycin improve survival without development physiologicallydefined cld regardless ureaplasma spp colonisation cannot recommended clinical practice uk national institute health care research