Congenital disorders requiring major pediatric surgical intervention are infrequent and present complex management problems. Most pediatric surgical studies are methodologically weak, single-center studies, and improved outcomes are likely to require a series of multi-center studies of exemplary quality. The applicant, Dr. Kevin Lally, the A.G. McNeese Professor and Chief of Pediatric Surgery at UT Houston, is a leader in promoting such studies. He has participated in 19 diaphragmatic hernia (CDH). CDH occurs in 1 per 2-4,000 live births; 35% of infants die; survivors are ventilated a mean of 18 days; and 34% have chronic lung disease. K24 funding is requested to substantially increase Dr. Lally's time for 1) Clinical Research including: a) A Multi-center placebo- controlled, randomized trial of antenatal steroids for infants with prenatally diagnosed CDH to improve their oxygenation and reduce time to ventilator independence. Fifteen centers have committed to participate; 7 have IRB approval; and 8, including UT-Houston, have GCRCs. The UT-Houston GCRC provides substantial statistical and database support for this trial. Collaborators at UT Houston include Drs. Larry Gilstrap and Jon Tyson, both experienced in steroid trials, and well-funded investigators in steroid trials, and well-funded investigators in the NICHD Maternal-Fetal and Neonatal Research Networks; and b) Extensive analyses of the CDH registry to define improved predictors of outcome, assess geographic differences and temporal trends, and develop hypotheses and descriptive data needed to design trials to improve outcome. This database has strict quality control, data on 1650 infants and 48 institutions now participate. 2) Mentoring Dr. Lally is a talented mentor; 3 current mentees have recently received a K08 award, a K23 award, and a Young Investigator Award. To enhance his mentoring skills, promote the funding and productivity in his Division of Pediatric Surgery, and augment his methodologic skills in clinical research, Dr. Lally will complete the NIH funded Clinical Research Curriculum work and assist with mentoring teams for young investigators in the Curriculum. He will also conduct systematic reviews of the Cochrane Collaboration and complete the Master's Degree Program in Clinical Research at UT-Houston. K24 funding will help Dr. Lally with his research and mentoring to advance the quality of clinical research in pediatric surgery, develop an expanded international trials network, and improve the outcome of high-risk infants.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
Midcareer Investigator Award in Patient-Oriented Research (K24)
Project #
5K24RR017050-03
Application #
6735597
Study Section
Surgery, Anesthesiology and Trauma Study Section (SAT)
Program Officer
Wilde, David B
Project Start
2002-06-01
Project End
2007-05-31
Budget Start
2004-06-01
Budget End
2005-05-31
Support Year
3
Fiscal Year
2004
Total Cost
$131,980
Indirect Cost
Name
University of Texas Health Science Center Houston
Department
Surgery
Type
Schools of Medicine
DUNS #
800771594
City
Houston
State
TX
Country
United States
Zip Code
77225
Kao, Lillian S; Tyson, Jon E; Blakely, Martin L et al. (2008) Clinical research methodology I: introduction to randomized trials. J Am Coll Surg 206:361-9
Harting, Matthew T; Blakely, Martin L; Cox Jr, Charles S et al. (2008) Acute hemodynamic decompensation following patent ductus arteriosus ligation in premature infants. J Invest Surg 21:133-8
Congenital Diaphragmatic Hernia Study Group; Lally, Kevin P; Lally, Pamela A et al. (2007) Defect size determines survival in infants with congenital diaphragmatic hernia. Pediatrics 120:e651-7
Radhakrishnan, Ravi S; Lally, Pamela A; Lally, Kevin P et al. (2007) ECMO for meconium aspiration syndrome: support for relaxed entry criteria. ASAIO J 53:489-91
Lally, Kevin P; Lally, Pamela A; Van Meurs, Krisa P et al. (2006) Treatment evolution in high-risk congenital diaphragmatic hernia: ten years' experience with diaphragmatic agenesis. Ann Surg 244:505-13
Harting, Matthew T; Blakely, Martin L; Jaffe, Norman et al. (2006) Long-term survival after aggressive resection of pulmonary metastases among children and adolescents with osteosarcoma. J Pediatr Surg 41:194-9
Hayes-Jordan, Andrea; Doherty, Debra K; West, Sonlee D et al. (2006) Outcome after surgical resection of recurrent rhabdomyosarcoma. J Pediatr Surg 41:633-8; discussion 633-8
Lally, Kevin P; Bagolan, Pietro; Hosie, Stuart et al. (2006) Corticosteroids for fetuses with congenital diaphragmatic hernia: can we show benefit? J Pediatr Surg 41:668-74; discussion 668-74
Blakely, Martin L; Tyson, Jon E; Lally, Kevin P et al. (2006) Laparotomy versus peritoneal drainage for necrotizing enterocolitis or isolated intestinal perforation in extremely low birth weight infants: outcomes through 18 months adjusted age. Pediatrics 117:e680-7
Blakely, Martin L; Lally, Kevin P; McDonald, Scott et al. (2005) Postoperative outcomes of extremely low birth-weight infants with necrotizing enterocolitis or isolated intestinal perforation: a prospective cohort study by the NICHD Neonatal Research Network. Ann Surg 241:984-9; discussion 989-94