This open, multicenter, randomized, controlled balloon was advised by the authors and conducted in 19 centers (41 NICUs) accommodating in the Neonatal Research Network of the Eunice Kennedy Shriver National Institute of Adolescent Health and Human Development (NICHD), in accord with the National Heart, Lung, and Claret Institute (NHLBI). Breed underwent randomization amid December 31, 2012, and April 12, 2017, with aftereffect through February 3, 2020.
Four of the authors active by RTI International, the abstracts analogous centermost for the Neonatal Research Network, undertook coordination, monitoring, and abstracts collection, storage, management, and analysis. The authors active by RTI International had abounding admission to all the abstracts in the balloon and booty albatross for the candor of the abstracts and the accurateness of the abstracts analysis. The aboriginal bristles authors and the aftermost columnist able a abstract of the manuscript, which was advised and accustomed by the balloon subcommittee and all armpit investigators. The NICHD and NHLBI agents had ascribe into the balloon design, conduct, analysis, and drafting of the manuscript. All the authors vouch for the accurateness and abyss of the advertisement and for the allegiance of the balloon to the balloon protocol.
Investigators at anniversary centermost (listed in Table S1 in the Supplementary Appendix, accessible at NEJM.org) and RTI International acquired approval of the institutional analysis lath at anniversary accommodating armpit and supervised the abreast accord action and balloon procedures. Written abreast accord was acquired from the ancestor or acknowledged guardian of anniversary child. Absolute blank was provided by the abstracts and assurance ecology board of the Neonatal Research Network, which included experts in neonatology, bioethics, and biostatistics, as able-bodied as a neonatal admixture specialist appointed for this balloon by the NHLBI.
Infants with a bearing weight of 1000 g or less, a gestational age amid 22 weeks 0 canicule and 28 weeks 6 days, and a postnatal age of 48 hours or beneath were acceptable to participate in the trial. Breed were afar if they were advised to be abstract by the accessory neonatologist, had cyanotic complete affection disease, had parents who were against to claret transfusion, had a ancestor with hemoglobinopathy or complete anemia, had accustomed a admixture in utero, had twin-to-twin admixture affection or isoimmune hemolytic disease, or had accustomed a antecedent red-cell admixture afterwards the aboriginal 6 hours of life. Added exclusion belief were the likelihood that the infant’s ancestors would not be able to acknowledgment for aftereffect appraisal at 22 to 26 months, cancellation or planned cancellation of erythropoietin, and a complete action (other than abortive birth) abnormally affecting activity assumption or neurodevelopment.
The breed were about assigned in a 1:1 arrangement to the higher- or lower-threshold group. Randomization was performed centrally by blast with the abstracts analogous center. Randomization was stratified according to bearing weight (<750 g or 750 to 1000 g) and balloon centermost and counterbalanced aural about called block sizes of two or four patients. Multiple-birth ancestors underwent randomization individually.
All accepted red-cell transfusions in both groups were guided by algorithms until the breed accomplished 36 weeks of postmenstrual age or acquittal from the NICU of the balloon hospital, whichever occurred aboriginal (Table S2). Admixture algorithms were constant with accepted practice,2,8 including convenance at accommodating Neonatal Research Network sites. We adhered to ethical recommendations apropos trials of dose-adjusted therapies.9 Claret admixture thresholds in both groups were bent according to postnatal age (highest in the aboriginal anniversary of life, lower in anniversary of the 2 alternating weeks, and abiding thereafter) and according to the use of respiratory abutment (a college beginning back respiratory abutment was warranted). Respiratory abutment was authentic as automated ventilation, connected complete airway pressure, a atom of aggressive oxygen (Fio2) greater than 0.35, or commitment of oxygen or allowance air by nasal cannula at a breeze of 1 liter per minute or more.
With complete adherence to these admixture algorithms throughout the analysis period, the beggarly between-group aberration in the pretransfusion claret levels was accepted to be 2.0 to 2.5 g per deciliter (20 to 25 g per liter). The admixture aggregate was 15 ml per kilogram of anatomy weight. All transfusions accustomed by the breed were from ABO-compatible and Rh-compatible donors. The clinicians were acceptable to aberrate from the applicative algorithm briefly for affidavit authentic in the acceding (e.g., if the baby had bleeding or advancing bleeding during or afterwards surgery, astringent hypoxemia, hypotension, or sepsis). All the claret transfusions were recorded and centrally advised for bendability with the algorithms; if they were inconsistent, they were accounted to be deviations. All deviations were apart adjudicated as actuality either justified by the acceding or violations according to acceding of two lath who were blind of the analysis assignments.
The primary aftereffect was a blended of afterlife or neurodevelopmental crime in breed at 22 to 26 months of age, adapted for prematurity. All the aftereffect examiners, including psychologists and psychometrists, were blind of the analysis assignments.
Neurodevelopmental crime was authentic as one or added of the afterward components: bookish delay, abstinent or astringent bookish palsy, or astringent eyes or audition loss. Bookish adjournment was authentic as a blended bookish account of beneath than 85 (1 SD beneath the beggarly of 100) on the Bayley Scales of Baby and Toddler Development, third edition10; array ambit from 55 to 145, with college array advertence bigger performance. Abstinent bookish attached was authentic as akin II or III in the Gross Motor Action Classification System (GMFCS) (levels ambit from I [mild impairment] to V [most astringent impairment]), and astringent bookish attached as GMFCS levels IV or V.11 Astringent eyes accident was authentic as a adapted beheld acuity in the bigger eye of beneath than 20/200. Astringent audition crime was authentic as mutual audition accident for which audition aids or circling implants were warranted, according to a audition appraisal conducted by complete acreage testing or according to testing of audition brain-stem responses. We prespecified that breed after abstinent or astringent bookish attached and after eyes or audition accident had to complete the bookish subtest of the Bayley Scales auspiciously in adjustment to be counted as hale for the blended primary outcome.
Table S3 lists all the prespecified accessory outcomes to aboriginal acquittal home and at 2 years of age. Prespecified accessory outcomes at 22 to 26 months of age included death, neurodevelopmental crime and its four components, and added abundant analyses of the blended cognitive, language, and motor array on the Bayley Scales. Afterwards a acceding change in 2013, the parents or guardians of the breed completed the Adolescent Behavior Checklist12 instead of the Brief Infant–Toddler Social and Emotional Appraisal in adjustment to accede with revised Neonatal Research Network aftereffect procedures.
Prespecified accessory neonatal outcomes included adaptation to antecedent hospital acquittal after astringent complications. These complications included brand 3 or 4 intraventricular hemorrhage, cystic periventricular leukomalacia, or ventriculomegaly diagnosed with the use of clinically performed ultrasonographic assay of the head13; date 3 or greater retinopathy of prematurity or cancellation of analysis for that condition14; and bronchopulmonary dysplasia diagnosed at 36 weeks of postmenstrual age on the base of a accurate charge for added oxygen (defined as an Fio2 of ≥0.30 or disability to canyon the oxygen abridgement analysis if the Fio2 was 0.22 to 0.29).15 Date 2 or 3 necrotizing enterocolitis was recorded.16 The infant’s arch circumference, weight, and breadth at a postmenstrual age of 36 weeks, postmenstrual age at the aftermost use of caffeine therapy, and the cardinal of arranged red-cell transfusions were additionally accessory outcomes. For anniversary transfusion, it was acclaimed whether the administering was according to the balloon protocol.
Our capital cold was to appraise the between-group aberration in the blended primary aftereffect of afterlife or neurodevelopmental crime at 22 to 26 months of age, adapted for prematurity. On the base of a antecedent trial,6 we accepted that there would be an complete between-group aberration of 7 allotment credibility in the accident of afterlife or neurodevelopmental impairment. Given a 52% accident of afterlife or neurodevelopmental crime (unpublished data) in the Neonatal Research Network in 2005–2008 (with access belief that were agnate to those in this trial), we affected aftereffect ante of 53.5% for the lower-threshold accumulation and 46.5% for the higher-threshold group, centered about a bourgeois all-embracing accident amount of 50% in the two analysis groups.. We estimated that with a sample of 1824 breed and 10% accident to follow-up, the balloon would accept 80% ability to ascertain an complete aberration of 7 allotment credibility in the accident of the primary aftereffect amid the balloon groups, at a two-tailed blazon I absurdity amount of 0.05.
The absolute abstracts and assurance ecology board advised the admission abstracts at four time credibility during the acceptance period, as prespecified by the balloon protocol. Because primary aftereffect abstracts were accessible alone at 22 to 26 months of follow-up, statistical acting ecology at four intervals focused on a blended assurance aftereffect of in-hospital death, necrotizing enterocolitis, or adverse allegation on ultrasonographic assay of the head. The acceptation of the acting assurance analyses with O’Brien–Fleming boundaries was affected with a Lan–DeMets spending action to bottle an all-embracing blazon I absurdity amount of 0.05 for the blended assurance outcome.
All the analyses were adapted for stratification according to birth-weight accumulation and center, and all the breed were evaluated according to analysis assignment. The primary aftereffect was analyzed with able-bodied Poisson corruption to access adapted about risks and 95% aplomb intervals. The bendability of the analysis aftereffect beyond birth-weight strata and sexes and analysis adverse beyond the assorted centers were advised by abacus acceptable alternation agreement to the adapted models. Binary accessory outcomes, including red-cell admixture outcomes, were analyzed with the use of able-bodied Poisson regression. Linear corruption was acclimated for the cardinal of transfusions received. Added accessory outcomes, such as the time to achieve bearing weight and time to abounding enteral feeding, were analyzed with Cox proportional-hazards adaptation regression, and abstracts were censored for deaths. There was no prespecified plan to acclimatize for complication of testing for the accessory outcomes, and a P amount is appear alone for the primary aftereffect (with a alternate P amount <0.05 advised to announce statistical significance); all the added analyses are exploratory. Analyses were conducted with the use of SAS software, adaptation 9.4 (SAS Institute).
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