Original ArticleFactors Affecting Growth in Infants with Single Ventricle Physiology: A Report from the Pediatric Heart Network Infant Single Ventricle Trial
Section snippets
Methods
Details of the ISV Trial study design and main results have been published.10, 11 In brief, ISV physiology between 1 week and 45 days of age with stable systemic and pulmonary blood flow in whom an SCPC (bidirectional Glenn anastamosis, bilateral bidirectional Glenn anastamosis, or hemi-Fontan procedure) was planned were enrolled. Exclusion criteria included gestational age <35 weeks, small for gestational age (<10th percentile), a recognizable chromosomal or phenotypic syndromes associated
Results
The clinical characteristics of the 230 subjects enrolled in the ISV Trial are shown in Table I (available at www.jpeds.com). Mean age at trial enrollment was 20.4 ± 9.0 days, and 63% of subjects had a diagnosis of hypoplastic left heart syndrome. Of the 230 subjects, 28 were withdrawn from the study before the pre-SCPC visit, and two did not have a pre-SCPC visit. Reasons for withdrawal included death in 15 subjects, transplant in two subjects, family choice in 8 subjects, physician choice in
Discussion
Growth failure is common in infants with congenital heart disease, including those with single ventricle physiology.5, 6, 8, 9, 13 There are likely multiple mechanisms contributing to growth failure in this population, including chronic cyanosis, alterations in energy expenditure,14, 15 inadequate caloric intake,16, 17 genetic factors,18 and alterations in serum growth factors and growth hormone.19 It can be difficult to achieve adequate nutrition in neonates with single ventricle physiology
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Cited by (0)
Supported by the National Heart, Lung, and Blood Institute (U01 grants HL068269, HL068270, HL068279, HL068281, HL068285, HL068292, HL068290, HL068288, HL085057) and the US Food and Drug Administration Office of Orphan Products Development. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of National Heart, Lung, and Blood Institute or National Institutes of Health. The authors declare no conflicts of interest.
Trial is registered at www.clinicaltrials.gov (NCT00113087).
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List of investigators of the Pediatric Heart Network is available at www.jpeds.com (Appendix).