Objective: to develop and evaluate a middle-range theory for the Nursing Diagnosis of Ineffective Breathing Pattern in children with congenital heart disease. Method: a methodological study carried out in two stages: 1) development of a middle- range theory for Ineffective Breathing Pattern in children with congenital heart diseases from the analysis of the NANDA-International taxonomy, Callista Roy’s Adaptation Model and a literature review; and 2) assessment of the middle-range theory developed using expert panel evaluation. Results: after three panel evaluations, the final version of the middle-range theory resulted in four metaparadigms, two key concepts, two pictorial diagrams, two propositions and a description of the interrelationships between the key concepts of Ineffective Breathing Pattern in children with congenital heart diseases and evidence for the Nursing practice. Conclusion: the middle-range theory developed and evaluated by experts identified stimuli and behaviors that can assist nurses in identifying the reasons why Ineffective Breathing Pattern is diagnosed and how it manifests itself in children with congenital heart disease, increasing understanding of the relationships between the causes and their temporality.