Randomized Clinical Trial of Metoclopramide as Prophylaxis of Gastroesophageal Reflux Disease in Preterm Infants.

BACKGROUND: Gastroesophageal reflux (GER) is more frequent in premature infants. Metoclopramide was introduced routinely in premature babies followed in ambulatory care by the Colombian Kangaroo Mother Care program (KMCP), based on a 2004 Cochrane review. AIM: Because of the recent controversy on the use of metoclopramide in children, this study was conducted to evaluate the effectiveness and safety of metoclopramide given as GER disease (GERD) prophylaxis. METHODS: A randomized clinical trial was conducted between April 2017 and January 2019 in 466 premature infants discharged home and followed at a KMCP. Double-blind allocation to metoclopramide versus placebo was performed, 0.2 mg/kg three times daily, administered 15 min before feeding, up to term. Exclusion criteria were oxygen dependency, any perinatal neurological problem or parent's participation refusal. The incidence of GERD symptoms and adverse events that could be associated with the use of metoclopramide were recorded by parents weekly (e.g., emesis, cyanosis or apnea, post-prandial crying episodes, extrapyramidal symptoms, tremor, and drowsiness). RESULTS: A total of 466 subjects were recruited, most of them late preterm. The groups' baseline characteristics were similar. Median duration of the intervention was approximately 3 weeks, at which time most patients were at term. In the longitudinal mixed effects analysis, we did not find clinically significant differences in GERD-related symptoms between groups, either in minor or severe side effects. CONCLUSION: Results show absence of effectiveness in the systematic use of metoclopramide as prophylaxis of GERD symptoms in premature infants. Additionally, no adverse effects attributable to the drug were found. ClinicalTrials.gov: NCT02907632; September 20, 2016. Retrospectively registered.

Anemia, nutrition, and ambulatory oxygen weaning in a cohort of oxygen-dependent premature infants.

BACKGROUND: In Bogotá, Colombia, oxygen-dependent (OD) preterm infants are home discharged in Kangaroo Position, to a Kangaroo Mother Care Program (KMCP) with ambulatory oxygen, strict follow-up, and oxygen weaning protocols. OBJECTIVES: (1) To describe growth, morbimortality, and oxygen monitoring up to 6 months in OD preterm infants. (2) To explore associations between oxygen weaning, perinatal history, Hb levels, transfusions, feeding patterns, and growth. METHODS: A prospective cohort study. Descriptive and multivariate analysis. RESULTS: Recruited patients were 407 with 33 weeks median gestational age (GA). Mothers presented infections >28%, pre-eclampsia in 22%, and 80% received antenatal corticosteroids. Upon KMCP admission, median GA, chronological age, and hospital stay were 36 weeks, 21 and 17 days, respectively; 56.8% of patients had neonatal sepsis and 67.8% were admitted to the neonatal intensive care unit. At oxygen weaning, patients had a median of 54 days with oxygen, median weight 3240 g and GA 41 weeks. Median follow-up oxygen saturation was 94% with 1/64-1/2 L/min of oxygen. One-year mortality was 0.2% and attrition 20%. At 6 months, all patients had appropriate growth and 67% were breastfeeding. Multiple regression analysis showed that higher GA, Hb levels, weight gain, and exclusive breastfeeding decreased oxygen requirement while invasive ventilation and transfusions had the opposite effect (R2 = .49). CONCLUSIONS: In OD preterm infants, there is a close relationship between days of oxygen requirement and GA, mechanical ventilation, Hb levels at discharge, transfusions, exclusive breastfeeding, and weight gain. Strict monitoring with established protocols in an ambulatory KMCP allows adequate growth and safe oxygen weaning.

Effectiveness and Safety of Fast Enteral Advancement in Preterm Infants Between 1000 and 2000 g of Birth Weight.

BACKGROUND: The advancement of enteral nutrition in premature infants is still controversial. Clinicians must provide adequate caloric intake but avoiding feeding intolerance and necrotizing enterocolitis (NEC). The aim of this study was to establish the safety and effectiveness of fast enteral advancement by comparing it with traditional advancement. METHODS: This is a controlled randomized clinical trial. Feeding was advanced at 30 mL/kg/d vs 20 mL/kg/d in premature infants under 34 weeks between 1000 and 1499g birth weight, and at 40 mL/kg/d vs 20 mL/kg/day in those weighing 1500-1999 g. Outcomes included time to reach total enteral nutrition, days of parenteral nutrition (PN) and/or intravenous fluid (IVF), days to recover birth weight, episodes of feeding intolerance, growth and weight gain at 40 weeks, sepsis, hypoglycemia, hyperbilirubinemia, NEC, and mortality. Student t-test or Mann-Whitney U test, Fisher test or χ2 test, and multiple linear regression were used. RESULTS: Differences were found in days to reach total enteral nutrition (slow: 7 [IQR(interquartile range), 6-9], fast: 4 [IQR, 4-6]; P < .001) and days of IVF or PN (slow: 6 [IQR, 4-8], fast: 3 [IQR, 3-5]; P < .001). Fast advancement decreases time to total enteral nutrition by 3 days and PN and/or IVF by up to 5 days. There were no differences in other outcomes. CONCLUSIONS: Fast enteral advancement decreases the days to reach total enteral nutrition and the days of PN and/or IVF without causing greater feeding intolerance. Additional studies are required for more evidence.

Caracterización de recién nacidos a término con diagnóstico de intolerancia a la vía oral en su primera semana de vida / Characterization of term new-born with diagnosis of feeding intolerance in first week of life

Introducción: El diagnóstico de intolerancia a la vía oral en los recién nacidos atérmino no se basa en la definición operativa. No hay estudios sobre factores de riesgo.Objetivo: Caracterizar a recién nacidos a término hospitalizados con diagnóstico deintolerancia a la vía oral. Analizar la calidad sobre este diagnóstico y establecer suincidencia real. Diseño y metodología: Cohorte retrospectiva entre 2011 y 2013. Seanalizaron variables prenatales, intraparto y postparto y si el diagnóstico cumplía conlos criterios de la definición. Resultados: El 11,3 % de los pacientes tenía intoleranciaa la vía oral, y solo el 33 % cumplía con la definición operativa. La incidencia anualestimada estuvo entre el 3,5 % y el 4,4 %. En la caracterización de la población, lasvariables más frecuentes fueron: consumo de fórmula láctea (88 %), antecedentematerno de anestesia regional (69 %), ictericia (61 %), sexo masculino (58 %), partopor cesárea (57 %) e hipoglucemia (53 %). Conclusiones: La incidencia real es similara otros países; el 66 % de los pacientes no cumplía con la definición operativa. Serequieren estudios analíticos que exploren la relación causal con las variables másfrecuentes.

Introduction : The diagnosis of feeding intolerance in at term newborns is not based on the operational definition. There are not studies on risk factors. Objective: To characterize term newborns hospitalized with a diagnosis of feeding intolerance. To develop a quality analysis about diagnostic and to establish real incidence. Design and Methods: Retrospective cohort between 2011 and 2013. Prenatal, intrapartum, and postpartum variables were analyzed as well as if the diagnosis met the criteria for the operational definition. Results: 11.3% of patients showed feeding intolerant, only 33% met the operational definition. The annual incidence was between 3.5% and 4.4%. In the characterization of the population, the most common variables were: consumption of artificial feeding (88%), maternal history of regional anesthesia (69%), jaundice (61%), male sex (58%), cesarean delivery (57 %), and hypoglycemia (53%). Conclusions: The incidence was similar to the one in other countries. 66% of patients did not meet the operational definition. Analytical depth studies exploring causal relationship are required.