Polyunsaturated fatty acids (PUFA) for attention deficit hyperactivity disorder (ADHD) in children and adolescents.

Context Daily growth hormone (GH) injections can be burdensome for patients and carers. Somapacitan is a long-acting, reversible albumin-binding GH derivative in development for once-weekly administration in patients with growth hormone deficiency (GHD). Objective The objective of this study is to evaluate the efficacy, safety, and tolerability of once-weekly somapacitan vs once-daily GH. Design REAL 3 is a multicenter, randomized, controlled, double-blind (somapacitan doses), phase 2 study with a 26-week main and 26-week extension phase (NCT02616562). Setting This study took place at 29 sites in 11 countries. Patients Fifty-nine GH treatment-naive prepubertal children with GHD were randomly assigned; 58 completed the trial. Interventions Interventions comprised 3 somapacitan doses (0.04 [n = 16], 0.08 [n = 15], or 0.16 mg/kg/wk [n = 14]) and daily GH (0.034 mg/kg/d [n = 14]), administered subcutaneously. Main Outcome Measures The primary end point was height velocity (HV) at week 26. Secondary efficacy end points included HV SD score (SDS) and insulin-like growth factor-I (IGF-I) SDS. Results At week 26, mean (SD) annualized HV for the somapacitan groups was 8.0 (2.0), 10.9 (1.9), and 12.9 (3.5) cm/year, respectively, vs 11.4 (3.3) cm/year for daily GH; estimated treatment difference (somapacitan 0.16 mg/kg/week—daily GH): 1.7 [95% CI –0.2 to 3.6] cm/year. HV was sustained at week 52, and significantly greater with somapacitan 0.16 mg/kg/week vs daily GH. Mean (SD) change from baseline in HV SDS at week 52 was 4.72 (2.79), 6.14 (3.36), and 8.60 (3.15) for the somapacitan groups, respectively, vs 7.41 (4.08) for daily GH. Model-derived mean (SD) IGF-I SDS for the somapacitan groups was −1.62 (0.86), −1.09 (0.78), and 0.31 (1.06), respectively, vs −0.40 (1.50) observed for daily GH. Safety and tolerability were consistent with the profile of daily GH. Conclusions In children with GHD, once-weekly somapacitan 0.16 mg/kg/week provided the closest efficacy match with similar safety and tolerability to daily GH after 26 and 52 weeks of treatment. A short visual summary of our work is available (1).

No abstract

Gastrointestinal manifestations in PIMS-TS are acute abdomen, diarrhea, and malena. However, there are no reports of per rectal bleeding in these children. A 4-mo-old female infant presented with fever, vomiting, lethargy and fresh blood in stool since 1 day. There was no abdominal distension but bowel sounds were sluggish. She was in compensated shock and needed fluid resuscitation, and respiratory and ionotropic support. Her investigations showed neutrophilic leucocytosis, raised inflammatory and cardiac markers, and sterile blood culture. Coronavirus disease 2019 (COVID-19) immunoglobulin G (IgG) antibodies were positive 6.26 S/CO (< 1.4) and reverse transcription polymerase chain reaction (RT-PCR) was negative. The father was COVID-19 RT-PCR positive one month back. She had 3 episodes of fresh blood in stool; hemoglobin dropped to 8 g/dL; needed transfusion. Echocardiography showed dilated both coronaries with high z score > 2.5 Computed tomography showed dilated jejunum and proximal ileum suggestive of obstruction. Exploratory laparotomy showed extensively congested ileum and tiny fibrous band about 2.5 cm crossing from antimesenteric border to mesentery in proximal ileum. No obvious volvulus was seen. This tiny band cannot cause ischemic changes unless accompanied by volvulus. She was treated with piperacillin-tazobactam, amikacin, immunoglobulin, and methylprednisolone following which inflammatory markers decreased and she was subsequently discharged. On follow-up, she had good weight gain and normal coronaries.