ABSTRACT. Introduction: the objective of this study was to make a clinical and epidemiological characterization of the patients with cleft lip and/or palate (CLP) who consulted at the Children’s Hospital Clinica Noel Foundation of Medellin, Colombia, South America, between 1985 and 2003. Methods: 919 clinical records were evaluated for a descriptive, longitudinal, retrospective study. A univariate statistical analysis was used for the qualitative variables, and descriptive measures for the quantitative ones. A two-variate statistical analysis was performed in order to determine the association among the qualitative variables with a significance level of 5%. Results: 50.3% of the cases were classified as unilateral and 19.8% as bilateral. Among the unilateral ones, 59.0% were located at the left side and 41.3% at the right side. 3.4% presented cleft lip, 12.4% presented cleft palate, and 12.8% presented cleft soft palate. 1.2% of the sample did not present pathology classification. In terms of gender, males represented 48.0% and females 38.1%; no data was found in 13.9% of the cases. Concerning location, 87.3% of the patients came from the State of Antioquia. As for age at the time of admission to the institution, 44.3% of the children were less than thirty days old. Most parents were between nineteen and thirty years old. Most medical records did not show reports on the father or mother’s family history, diseases during pregnancy or tobacco and alcohol consumption during pregnancy. Conclusions: this study evaluated the clinical records used at the Clinica Noel Foundation. As a result, we recommend to homogenize the professionals who fill in the records and to standardize the instruments in order to generate reliable databases for future research. RESUMEN. Introduccion: el objetivo de este estudio consistio en caracterizar clinica y epidemiologicamente pacientes con labio y/o paladar hendido (LPH) que consultaron el Hospital Infantil Clinica Noel de Medellin, Colombia, entre 1985 y 2003. Metodos: se evaluaron 919 historias clinicas, para un estudio de tipo descriptivo, longitudinal y retrospectivo. Se realizo un analisis univariado para las variables cualitativas, y medidas descriptivas para las variables cuantitativas. Se realizo analisis bivariado para determinar la asociacion entre las variables cualitativas con un nivel de significancia del 5%. Resultados: 50,3% de los casos fueron clasificados como unilaterales y 19,8% como bilaterales. Dentro de los unilaterales, el 59,0% se presentaron al lado izquierdo y el 41,3% al lado derecho. El 3,4% presento labio hendido, el 12,4% presento paladar duro hendido, y el 12,8% presento paladar blando hendido. El 1,2% de la muestra no incluia clasificacion de la patologia. En cuanto al sexo, los hombres representaron 48,0% y las mujeres 38,1%; no se encontraron datos en el 13,9%. El 87,3% de los pacientes provenian del departamento de Antioquia. La edad predominante de ingreso a la Fundacion fue antes de treinta dias de nacido. La mayoria de los padres estaban entre diecinueve y 30 anos de edad. La mayoria de las historias clinicas no tenian reporte acerca de historia familiar de la madre y el padre, enfermedades sufridas durante el embarazo o consumo de cigarrillo y bebidas alcoholicas durante el embarazo. Conclusiones: este estudio permitio evaluar la historia clinica usada en la Fundacion Clinica Noel. Se sugiere calibrar los profesionales que diligencian los registros, y estandarizar los instrumentos para generar una base de datos confiable para futuras investigaciones.