Early intervention program for very low birth weight preterm infants and their parents: a study protocol.

BACKGROUND: Preterm infants are high risk for delayed neurodevelopment. The main goal is to develop a program of early intervention for very preterm infants that allows families to apply it continuously at home, and quantify the results of early parental stimulation on improvement of cognition and motor skills. METHODS: Randomized clinical Trial including inborn preterm infants with gestational age less than 32 weeks or birth weight less than 1500 g at 48 h after birth. Eligible for begin the intervention up to 7 days after birth. Study Protocol approved by the Brazilian national Committee of ethics in Research and by the institutional ethics committee. Intervention group (IG): skin-to skin care by mother (kangaroo care) plus tactile-kinesthetic stimulation by mothers from randomization until hospital discharge when they receive a program of early intervention with 10 parents' orientation and a total of 10 home visits independently of the standard evaluation and care that will be performed. Systematic early intervention program will be according to developmental milestones, anticipating in a month evolutionary step acquisition of motor and / or cognitive expected for corrected age. Active comparator with a Conventional Group (CG): standard care according to the routine care of the NICU and their needs in the follow up program. Neurodevelopment outcome with blinded evaluations in both groups between 12 and 18 months by Bayley Scales of Infant and Toddler Development third edition and Alberta Motor Infant scale will be performed. All evaluations will be conducted in the presence of parents or caregivers in a safe room for the child move around during the evaluation. DISCUSSION: If we can show that a continuous and global early intervention at home performed by low income families is better than the standard care for very preterm infants, this kind of program may be applied elsewhere in the world. We received grants by Bill and Melinda Gates Foundation, DECIT, Cnpq and Health Ministry. Grand Challenges Brazil: All Children Thriving. TRIAL REGISTRATION: The study was restrospectively registered in ClinicalTrials.gov . in July 15 2016 ( NCT02835612 ).

Association of late-onset neonatal sepsis with late neurodevelopment in the first two years of life of preterm infants with very low birth weight / Associação de sepse neonatal tardia com atraso do neurodesenvolvimento nos primeiros dois anos de vida de recém-nascidos pré-termos de muito baixo peso

OBJECTIVE: To establish the influence of late-onset sepsis on neurodevelopment of preterm infants with very low birth weight (VLBW), according to the etiologic agent METHOD: This was a cohort of newborns with birth weight < 1,500 g and gestational age less than 32 weeks, admitted to the institutional intensive care unit (ICU) with up to 48 hours of life, and followed-up at the outpatient follow-up clinic for preterm infants with VLBW until 2 years of corrected age. Exclusion criteria: death within the first 72 hours of life, congenital malformations and genetic syndromes, children with congenital infection by the human immunodeficiency virus (HIV), congenital infection (STORCH), presence of early-onset spesis and cases with more than one pathogen growth in blood cultures. Septic and non-septic infants were compared regarding neonatal outcomes and mortality. Neurodevelopment was assessed using the Bayley Scale (BSDI-II) at 18 to 24 months of corrected age. RESULTS: 411 preterm infants with VLBW were eligible; the mean gestational age was 29 ± 2.2 weeks and mean birth weight was 1,041 ± 281grams. Late-onset sepsis occurred in 94 preterm infants with VLBW (22.8%). VLBW infants with Gram-positive infection showed motor deficit when compared to the non-septic group, 68.8% vs. 29.3%, respectively (OR 6; 1.6-21.8, p = 0.006); the cognitive development was similar between the groups. The overall mortality rate from infection was 26.7%; considering the pathogens, the rates were 18.7% for coagulase-negative Staphylococcus, 21.8% for Gram-positive bacteria, and 50% for Gram-negative bacteria and fungi. CONCLUSION: Neonatal sepsis has a significant influence on late neurodevelopment at 2 years of corrected age in preterm infants with VLBW, and Gram-positive infections are associated with motor deficit. .

OBJETIVO: Estabelecer a influência da sepse tardia no neurodesenvolvimento de prematuros de muito baixo peso (MBP) recém-nascidos (RNs) de acordo com o agente etiológico. MÉTODOS: Coorte de RN com peso de nascimento < 1.500 g e idade gestacional < 32 semanas,internados na UTI da instituição dentro de 48 horas de vida, e atendidos no ambulatório de MBP para até dois anos de idade corrigida. Foram excluídos: a morte nas primeiras 72 h de vida, malformações congênitas e síndromes genéticas, filhos de mães HIV-positivas e infecção congênita, presença de sepse precoce, e os casos com mais de um microorganismo identificado em hemoculturas. RNs sépticos e não sépticos foram comparados quanto resultados neonatais, mortalidade e neurodesenvolvimento avaliados através das escalas Bayley (BSDI-II) aos 18-24 meses de idade corrigida. RESULTADOS: Um total de 411 RNs prematuros de muito baixo peso eram elegíveis, com idade gestacional = 29 ± 2,2 semanas e peso de nascimento = 1.041 ± 281 g. Sepse tardia ocorreu em 94 casos (22,8%). MBP RN com infecção causada por microrganismos Gram-positivos apresentaram atraso motor, quando comparado com o grupo sem sépsis - 68,8% vs 29,3% (OR 6; 1,6-21,8,p = 0,006), e atraso cognitivo, foi semelhante. Taxa de mortalidade global de infecção foi de 26,7%, e as taxas de mortalidade por grupo microorganismo foram: Staphylococcus coagulase negativa, 18,7%; Gram-positivos, 21,8%; Gram-negativas e fungos, 50%. CONCLUSÃO: A sepse neonatal tem uma influência significativa no atraso no desenvolvi mento neuropsicomotor aos dois anos de idade corrigida em prematuros de muito baixo peso RN e as infecções por germes gram-positivos estão associadas com atraso motor. .

Association of late-onset neonatal sepsis with late neurodevelopment in the first two years of life of preterm infants with very low birth weight.

OBJECTIVE: To establish the influence of late-onset sepsis on neurodevelopment of preterm infants with very low birth weight (VLBW), according to the etiologic agent. METHOD: This was a cohort of newborns with birth weight<1,500 g and gestational age less than 32 weeks, admitted to the institutional intensive care unit (ICU) with up to 48 hours of life, and followed-up at the outpatient follow-up clinic for preterm infants with VLBW until 2 years of corrected age. EXCLUSION CRITERIA: death within the first 72 hours of life, congenital malformations and genetic syndromes, children with congenital infection by the human immunodeficiency virus (HIV), congenital infection (STORCH), presence of early-onset sepsis and cases with more than one pathogen growth in blood cultures. Septic and non-septic infants were compared regarding neonatal outcomes and mortality. Neurodevelopment was assessed using the Bayley Scale (BSDI-II) at 18 to 24 months of corrected age. RESULTS: 411 preterm infants with VLBW were eligible; the mean gestational age was 29 ± 2.2 weeks and mean birth weight was 1,041 ± 281 grams. Late-onset sepsis occurred in 94 preterm infants with VLBW (22.8%). VLBW infants with Gram-positive infection showed motor deficit when compared to the non-septic group, 68.8% vs. 29.3%, respectively (OR 6; 1.6-21.8, p=0.006); the cognitive development was similar between the groups. The overall mortality rate from infection was 26.7%; considering the pathogens, the rates were 18.7% for coagulase-negative Staphylococcus, 21.8% for Gram-positive bacteria, and 50% for Gram-negative bacteria and fungi. CONCLUSION: Neonatal sepsis has a significant influence on late neurodevelopment at 2 years of corrected age in preterm infants with VLBW, and Gram-positive infections are associated with motor deficit.