Ranibizumab after laser photocoagulation failure in retinopathy of prematurity (ROP) treatment.

The purpose of this study was to investigate the anatomical and functional outcomes of the two-stage treatment of severe retinopathy of prematurity (ROP) using laser photocoagulation and intravitreal ranibizumab injection. The medical records of 53 eyes of 28 infants treated by conventional laser photocoagulation with deferred intravitreal 0.25 mg/0.025 mL ranibizumab injection were analysed. All patients had at least 11 months of follow-up. In the analysed group, the mean gestational age at birth was 25 weeks and mean birthweight was 790 g. The mean time of laser photocoagulation was 34 weeks of postmenstrual age (PMA). Ranibizumab injection was performed on average at 37 weeks of PMA. The mean time between interventions was 19 days. Retinal detachment occurred in 12 eyes (22.6%), in three children bilaterally. Visual responses were obtained in 23 of 28 treated children. Our results indicate that ranibizumab injection can be taken into consideration in the selected cases of laser photocoagulation failure. The unsatisfactory results of this study elicited a change in the ROP treatment protocol in our medical centre. The study gives an insight into anatomical and functional outcomes of ROP treatment in the Central and Eastern European population.

Recombinant Bile Salt-Stimulated Lipase in Preterm Infant Feeding: A Randomized Phase 3 Study.

INTRODUCTION: Feeding strategies are critical for healthy growth in preterm infants. Bile salt-stimulated lipase (BSSL), present in human milk, is important for fat digestion and absorption but is inactivated during pasteurization and absent in formula. This study evaluated if recombinant human BSSL (rhBSSL) improves growth in preterm infants when added to formula or pasteurized breast milk. PATIENTS AND METHODS: LAIF (Lipase Added to Infant Feeding) was a randomized, double-blind, placebo-controlled phase 3 study in infants born before 32 weeks of gestation. The primary efficacy variable was growth velocity (g/kg/day) during 4 weeks intervention. Follow-up visits were at 3 and 12 months. The study was performed at 54 centers in 10 European countries. RESULTS: In total 415 patients were randomized (rhBSSL n = 207, placebo n = 208), 410 patients were analyzed (rhBSSL n = 206, placebo n = 204) and 365 patients were followed until 12 months. Overall, there was no significantly improved growth velocity during rhBSSL treatment compared to placebo (16.77 vs. 16.56 g/kg/day, estimated difference 0.21 g/kg/day, 95% CI [-0.40; 0.83]), nor were secondary endpoints met. However, in a predefined subgroup, small for gestational age infants, there was a significant effect on growth in favor of rhBSSL during treatment. The incidence of adverse events was higher in the rhBSSL group during treatment. CONCLUSIONS: Although this study did not meet its primary endpoint, except in a subgroup of infants small for gestational age, and there was an imbalance in short-term safety, these data provide insights in nutrition, growth and development in preterm infants. TRIAL REGISTRATION: ClinicalTrials.gov NCT01413581.

The results of newborn hearing screening by means of transient evoked otoacoustic emissions.

OBJECTIVE: The incidence of sensorineural hearing loss is between 1 and 3 per 1000 in healthy neonates and 2-4 per 100 in high-risk children. Transient evoked otoacoustic emissions (TEOAEs) represent a method which can be applied to all newborns prior to hospital discharge, enabling early identification of hearing loss. The aim of the study was to evaluate the results of newborn hearing screening by means of TEOAEs. METHODS: Between 01.10.2002 and 30.09.2003, 5601 newborns born in the University Hospital in Poznan, Poland were screened with ERO SCAN (MAICO). Healthy neonates were screened in the second or third day of life and children treated in pathology unit--when their general condition was stable. The risk factors of hearing loss were recorded in a questionnaire. Children who failed the screening test or had risk factors of hearing impairment were referred to the outpatient clinic for further evaluation. RESULTS: Risk factors were identified in 739 newborns. The most often risk factors were: use of ototoxic drugs, low Apgar score and prematurity. Positive test result was obtained in 219 (3.91%) children unilaterally and in 137 (2.45%) bilaterally. In healthy children the prevalence of positive results was 3.56% and in high-risk infants 24.9%. The relative risk of positive test results was the highest in infants with positive family history (RR=7.5), congenital malformations (RR=6.7) and low Apgar score (RR=5). Of the group of 912 children, who were referred to the specialist, only 218 turned up to be assessed during the observation period and had the additional otoacoustic emission test performed. There was not any significant difference in the percentage of children with and without risk factors who turned up for the second test and in whom the result was positive (39.7% versus 40.3%). In 41.9% children with risk factors whose screening test was negative, the second exam gave positive result. CONCLUSIONS: The incidence of positive results in newborn hearing screening is much higher than the prevalence of hearing loss in general population and these results need verification by more precise methods. However, TEOAEs enable to select children who should be referred for audiological evaluation.