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M C Fadous Khalife

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  1. Hadi kabbout started following M C Fadous Khalife
  2. QUESTION (P) Among preterm infants born at less than 37 weeks’ gestation diagnosed with inguinal hernia during initial hospitalization, (I/C) does inguinal hernia repair before NICU discharge when compared to repair after NICU discharge and 55 weeks’ postmenstrual age (O) lead to more serious adverse events (T) in a 10-month observation period after randomization? METHODS Design: Multicenter, randomized clinical trial Allocation: The infants were randomly assigned when approximately 2 weeks away from anticipated NICU discharge in a 1:1 ratio to either early or late repair.Randomization was performed continuously in permutated blocks ranging from 2 to 4 in size and stratified by center and gestational age. The specific treatment group allocation was concealed until the infants were randomized. Blinding: Given the timing of repair as the primary intervention, blinding the clinicians to the study intervention was not feasible.However, the primary outcome was determined by a committee blinded to which intervention the patient received. Follow-up period: 10 months after initial randomization, follow-up at 2 years corrected age is ongoing. Setting: 39 medical centers in the United States Patients: Inclusion criteria: preterm infants born at less than 37 weeks’ gestation who were diagnosed with inguinal hernia by a pediatric surgeon during initial hospitalization to participating center between September 2013 and April 2021 Exclusion criteria: clinical factors that exclude early inguinal hernia repair, inguinal hernia repair planned as secondary procedure to another operative procedure, known major congenital or chromosomal anomaly, family unable to return for follow-up and late inguinal hernia repair. Intervention: Early inguinal hernia repair, which was defined as repair promptly after randomization and prior to NICU discharge, versus late inguinal hernia repair, which was defined as repair performed when the infant was older than 55 weeks postmenstrual age. Outcomes: Primary outcome: the proportion of infants with at least one serious adverse event during 10-month observation period.Serious adverse events were categorized into pulmonary events, cardiac events, surgical events, events related to hernia, or death. Secondary outcome: number of days in hospital during 10-month observation period, including neonatal intensive unit stay after randomization. Analysis and Sample Size: The authors made a priori hypothesis that the early repair group would have a 10% higher rate of severe adverse events than the late repair group.To have 80% power to detect a difference of this size, a sample size of 586 infants was required. The authors assumed a 5% loss rate, so they had planned to enroll 615 infants. For this study, an intention-to-treat analysis was performed.Frequentist and Bayesian analyses were both prespecified in the trial protocol. A logistic mixed-effects model was used to analyze the primary outcome, and a negative binomial mixed model was used for the secondary outcome.Gestational age was included as a covariate and study site as a random intercept. All Bayesian analyses used neutral priors, with a prior centered at an odds ratio of 1.0 with a 95% credible interval (CrI) of 0.33 to 3.0. Prespecified secondary analyses included stratification by gestational age categories, diagnosis of bronchopulmonary dysplasia (BPD), and open vs laparoscopic approach. A formal interim analysis was performed at 50% of anticipated enrollment which found a 97% probability of decreased rate of severe adverse events in the late repair group.This exceeded the stopping threshold of 95% and trial enrollment was stopped. Patient follow-up: A total of 1514 infants were assessed for eligibility of which 338 were randomized.A total of 18 infants (9 in each arm) did not undergo treatment as randomized, and a total of 12 infants (4 in early repair group and 8 in late repair group) were lost to follow-up. As such, 308 of the 338 randomized (91%) were included in primary analysis. Funding: This trial was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, U01 HD076733 (awarded to Dr. Blakely). MAIN RESULTS The study population was predominantly male (86%), and the median birthweight was 820 g (IQR, 640-1040 g). There were no significant differences between the two repair groups at enrollment other than the early repair group had slightly more apnea requiring intervention (85% v 79%). In the early repair group, the median post menstrual age at repair was 41 weeks (IQR, 39-44 weeks) and median weight was 3.1 kg (IQR, 2.5-3.6 kg). In the late repair group, the median post menstrual age at repair was 57 weeks (IQR, 52-61 weeks) and median weight was 5.9 kg (IQR, 4.7-6.9 kg). A greater percentage of procedures were laparoscopic in the early repair group than late repair (43% v 36%), and the duration of repair was shorter in the early repair group (57 min v 70 min). For the primary outcome, 44 of the 159 infants (28%) in the early repair group had at least 1 serious adverse event compared to 27 of the 149 (18%) in the late repair group (RR 0.68,95% CrI, 0.45 to 1.01). The posterior probability of benefit for the primary outcome was 97%. The relative risk was 0.61 (95% CrI, 0.39 to 0.94) in infants younger than 28 weeks’ gestation, and 0.92 (95% CrI, 0.47 to 1.75) in infants older than 28 weeks’ gestation. The relative risk was 0.50 (95% CrI, 0.27 to 0.87) in infants with BPD, and 0.85 (95% CrI, 0.51 to 1.37) in infants without BPD. For the secondary outcome, the median number of days in the hospital was 19 (IQR, 9.8 to 35 days) for the early repair group and 16 (IQR, 7 to 38 days) for the late repair group (RR 0.91, 95% CrI, 0.74 to 1.11), with an 82% posterior probability of benefit. CONCLUSION In preterm infants with inguinal hernia, the late repair strategy led to fewer infants with serious adverse events. A greater effect was noted in infants born at less than 28 weeks’ gestation or with BPD. Furthermore, there was also a high probability that later repair was associated with fewer overall hospital days. Based on these findings, the authors suggest that inguinal hernia repair after NICU discharge may be preferred I was just reading this on EBNEO july 2024 and I did bring it to the forum for discussion. Can you share your experience?
  3. At birth, we give vitamin K once per day for 3 days since we received a case who died from bleeding from vitamin K deficiency despite receiving his shot at birth. Later on, it depends on a case-by-case evaluation( long-term parenteral nutrition, bleeding tests disturbed, etc...) We also try to get to oral ( through an NG tube) very quickly.
  4. We started pulse oximetry before discharge at the maternity ward according to the Pediatric Cardiologist's advice but did not pick any case till now—the initial check at birth dates from more than 10 years.
  5. We participated in an initiative The American University started for antibiotic stewardship in neonatology, and I consider it a success. It made us stop some bad habits, reconsider the duration of anti-biotherapy, and encouraged us to stop ATB instead of waiting unnecessarily for cultures in some evident cases.
  6. We have a lot of processing errors so we never consider before 6,0
  7. Thank you for sharing. I registered
  8. Verey interesting study. I'm interested in obtaining information on the regulations regarding the parameters of nasal high frequency, particularly for very preterm infants."
  9. @Stefan Johansson Thx for your answer. I attended'' Journées Parisiennes de Pédiatrie '' in Paris, 5-6 October where all conferences were for probiotics use, and then saw what was posted on October 4. We needed to clarify it. Best,
  10. "Can I ask which type of probiotics you are using, Katja? Which product did you use before, and which one are you using now?" Thx for sharing
  11. Thanks Bernhard for sharing this app. Why do they mention not to use this tool within first 48 hours? And do you have any idea on which curves these web calculations are based?
  12. We use MCT oil as fortifier especially when weight growth curve is not progressing and in BPD
  13. This is all I found for you An approach to the management of hyperbilirubinemia in the preterm infant less than 35 weeks of gestation. J Perinatol 2012;32:660–4 Otherwise, I do convert mg per dl to micromoles & use the 10% of weight formula
  14. For me it is the NCPNN network based at the american university covering the majority of NICUs The tricky question is : Is there a common network receiving all datas filled till today