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Figure 1 | BMC Pediatrics

Figure 1

From: Description of the methodology used in an ongoing pediatric care interventional study of children born with cleft lip and palate in South America [NCT00097149]

Figure 1

Study Design. Figure 1 presents a flowchart of the study design of the neonatal and the two-year subprojects. All infants born with a typical form of cleft lip and palate in the study hospitals are enrolled in the neonatal subproject. Only isolated cases with both cleft of lip and cleft palate who are singleton births, normal birth weight, and without complications other than cleft lip and palate that require systematic care are enrolled at birth in the two-year subproject and randomized into intervened and non-intervened groups. A group of healthy controls is matched to the non-intervened group by gender, date and hospital of birth at a ratio of 2 to 1. A = Evaluating the impact of the intervention on neonatal mortality. B1 = Evaluating the impacts of cleft lip and palate on child's development and family socioeconomic outcomes (Two-year subproject). B2 = Evaluating the impact of the two-year intervention on child development and family socioeconomic outcomes.

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