PurposeRemote ischemic conditioning (RIC) is a maneuver involving brief cycles of ischemia reperfusion in an individual's limb. In the early stage of experimental NEC, RIC decreased intestinal injury and prolonged survival by counteracting the derangements in intestinal microcirculation. A single-center phase I study demonstrated that the performance of RIC was safe in neonates with NEC. The aim of this phase II RCT was to evaluate the safety and feasibility of RIC, to identify challenges in recruitment, retainment, and to inform a phase III RCT to evaluate efficacy. MethodsRIC will be performed by trained research personnel and will consist of four cycles of limb ischemia (4-min via cuff inflation) followed by reperfusion (4-min via cuff deflation), repeated on two consecutive days post randomization. The primary endpoint of this RCT is feasibility and acceptability of recruiting and randomizing neonates within 24 h from NEC diagnosis as well as masking and completing the RIC intervention. ResultsWe created a novel international consortium for this trial and created a consensus on the diagnostic criteria for NEC and protocol for the trial. The phase II multicenter-masked feasibility RCT will be conducted at 12 centers in Canada, USA, Sweden, The Netherlands, UK, and Spain. The inclusion criteria are: gestational age < 33 weeks, weight ≥ 750 g, NEC receiving medical treatment, and diagnosis established within previous 24 h. Neonates will be randomized to RIC (intervention) or no-RIC (control) and will continue to receive standard management of NEC. We expect to recruit and randomize 40% of eligible patients in the collaborating centers (78 patients; 39/arm) in 30 months.Bayesian methods will be used to combine uninformative prior distributions with the corresponding observed proportions from this trial to determine posterior distributions for parameters of feasibility. ConclusionsThe newly established NEC consortium has generated novel data on NEC diagnosis and defined the feasibility parameters for the introduction of a novel treatment in NEC. This phase II RCT will inform a future phase III RCT to evaluate the efficacy and safety of RIC in early-stage NEC.

Background Lipid‐injectable emulsions (ILEs) are a necessity for neonates dependent on parenteral nutrition (PN). In this manuscript, we describe the patterns of ILE use in neonatal intensive care units (NICUs) in the United States (US). Methods An electronic survey was sent to 488 NICUs across the US between December 2020 and March 2021. Survey fields included availability and utilization of various ILE in neonates. Results The response rate was 22% (107 out of 488). Soybean oil ILE (SO‐ILE) and soybean oil, medium‐chain triglycerides, olive oil, fish oil ILE (SO, MCT, OO, FO‐ILE) had similar availability (87% vs 86%, respectively), and SO, MCT, OO, FO‐ILE was more commonly used (SO‐ILE, 71% vs SO, MCT, OO, FO‐ILE, 86%). Fish oil‐ILE (FO‐ILE) was used by 55% of centers. SO‐ILE was most frequently used with PN and needs <4 weeks without cholestasis (79%). The most common reason for SO, MCT, OO, FO‐ILE use was cholestasis (71%). ILE minimization was used by 28% of SO‐ILE and 22% of SO, MCT, OO, FO‐ILE users; 95% of these centers restrict SO, MCT, OO, FO‐ILE to doses ≤2 g/kg/day. Twenty‐two percent of centers started FO‐ILE at direct bilirubin of >5 mg/dl. Conclusion The results of this survey reveal significant variability in ILE usage across the US. Lipid minimization with SO, MCT, OO, FO‐ILE and initiation of FO‐ILE for cholestasis at higher bilirubin thresholds are prevalent. Such reports are crucial for a better understanding of ILE use in the NICU and in future ILE development.

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obin sequence (RS), also known as Pierre Robin sequence, 1 is defined as the triad of micrognathia, glossoptosis, and upper airway obstruction. 2 A cleft of the secondary palate, although not required for the diagnosis, is present in approximately 50% to 90% of infants with RS. 3,4 RS occurs in 1 in 8500 to 20,000 live births. 5,6 The term RS describes a phenotype with diverse etiopathogenesis; RS may be initiated by intrauterine growth restriction or other nongenetically based stimuli, or as the result of more than 100 associated syndromes. 7 As a result, affected infants exhibit a wide spectrum of severity and associated congenital anomalies.Nonoperative treatment measures, including side or prone positioning, supplemental or positive airway pressure oxygen delivery, nasopharyngeal airways, or oral appliances with velar Background: Studies of infants with micrognathia, especially Robin sequence, are limited by its rarity and both phenotypic and diagnostic variability. Most knowledge of this condition is sourced from small, single-institution samples. Methods: This is a cross-sectional study including infants with micrognathia admitted to 38 Children's Hospital Neonatal Consortium centers from 2010 through 2020. Predictor variables included demographic data, birth characteristics, cleft, and syndrome status. Outcome variables included length of stay, death, feeding or respiratory support, and secondary airway operations. Results: A total of 1289 infants with micrognathia had surgery to correct upper airway obstruction. Mean age and weight at operation were 34.8 ± 1.8 weeks and 3515.4 ± 42 g, respectively. A syndromic diagnosis was made in 150 (11.6%) patients, with Stickler (5.4%) and Treacher Collins (2.2%) syndromes being the most common. Operations included mandibular distraction osteogenesis (MDO) in 66.3%, tracheostomy in 25.4%, and tongue-lip adhesion (TLA) in 8.3%. Patients receiving a tracheostomy had lower birthweight, head circumference, gestational age, and Apgar scores. Patients undergoing MDO were less likely to need a second airway operation compared with patients undergoing TLA (3.5% versus 17.8%; P < 0.001). The proportion of infants feeding exclusively orally at hospital discharge differed significantly, from most to least: MDO, TLA, and tracheostomy. Hospital length of stay was not statistically different for patients who had MDO or TLA, but was longer for those with primary tracheostomy. The mortality rate was low for all operations (0.5%). Conclusions: In this surgical patient cohort, MDO was associated with shorter hospital stay, improved oral feeding, and lower rates of secondary airway operations. Prospective multicenter studies are necessary to support these conclusions.

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