Chylous Pleural Effusion Following Cardiothoracic Surgery Clinical Trial
Official title:
A Comparison of the Effectiveness of Fortified Skimmed Mother's Milk Versus Specialized Formula in the Management of Chylous Effusion in Infants Following Cardiothoracic Surgery
The purpose of this study is to determine if the use of fortified skimmed mother's milk is a safe alternative to specialized formula in the treatment of chylothorax following cardiothoracic surgery.
| Status | Completed |
| Enrollment | 17 |
| Est. completion date | September 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 12 Months |
| Eligibility |
Inclusion Criteria: - Infant birth to 12 months of age - Undergo cardiothoracic surgery - Develop a chylous effusion - Be a breastfed or formula fed infant Exclusion Criteria: - Infant over 12 months of age - Infant in state custody (foster care) - Infant with milk protein allergy - Infant born with congenital chylothorax - Infant who develops chylothorax from other surgeries (non-cardiac |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Oregon Health and Science University - Doernbecher Children's Hospital | Portland | Oregon |
| Lead Sponsor | Collaborator |
|---|---|
| Oregon Health and Science University | The Gerber Foundation |
United States,
Allen EM, van Heeckeren DW, Spector ML, Blumer JL. Management of nutritional and infectious complications of postoperative chylothorax in children. J Pediatr Surg. 1991 Oct;26(10):1169-74. — View Citation
Beghetti M, La Scala G, Belli D, Bugmann P, Kalangos A, Le Coultre C. Etiology and management of pediatric chylothorax. J Pediatr. 2000 May;136(5):653-8. — View Citation
Berseth CL, Mitmesser SH, Ziegler EE, Marunycz JD, Vanderhoof J. Tolerance of a standard intact protein formula versus a partially hydrolyzed formula in healthy, term infants. Nutr J. 2009 Jun 19;8:27. doi: 10.1186/1475-2891-8-27. — View Citation
Bond SJ, Guzzetta PC, Snyder ML, Randolph JG. Management of pediatric postoperative chylothorax. Ann Thorac Surg. 1993 Sep;56(3):469-72; discussion 472-3. — View Citation
Büttiker V, Fanconi S, Burger R. Chylothorax in children: guidelines for diagnosis and management. Chest. 1999 Sep;116(3):682-7. — View Citation
Chan EH, Russell JL, Williams WG, Van Arsdell GS, Coles JG, McCrindle BW. Postoperative chylothorax after cardiothoracic surgery in children. Ann Thorac Surg. 2005 Nov;80(5):1864-70. — View Citation
Chan GM, Lechtenberg E. The use of fat-free human milk in infants with chylous pleural effusion. J Perinatol. 2007 Jul;27(7):434-6. Epub 2007 Jun 7. — View Citation
Chatterjee R, Chatterjee S, Datta T, Roy B, Marimuthu P. Longitudinal study of human milk creamatocrit and weight gain in exclusively breastfed infants. Indian Pediatr. 1997 Oct;34(10):901-4. — View Citation
Cormack BE, Wilson NJ, Finucane K, West TM. Use of Monogen for pediatric postoperative chylothorax. Ann Thorac Surg. 2004 Jan;77(1):301-5. Review. — View Citation
Le Coultre C, Oberhänsli I, Mossaz A, Bugmann P, Faidutti B, Belli DC. Postoperative chylothorax in children: differences between vascular and traumatic origin. J Pediatr Surg. 1991 May;26(5):519-23. — View Citation
Lessen R. Use of skim breast milk for an infant with chylothorax. ICAN: Infant, Child, & Adolescent Nutrition. 2009; 1(6):303-310.
Lewis CC, Scott DE, Pantell RH, Wolf MH. Parent satisfaction with children's medical care. Development, field test, and validation of a questionnaire. Med Care. 1986 Mar;24(3):209-15. — View Citation
Lucas A, Gibbs JA, Lyster RL, Baum JD. Creamatocrit: simple clinical technique for estimating fat concentration and energy value of human milk. Br Med J. 1978 Apr 22;1(6119):1018-20. — View Citation
Milonakis M, Chatzis AC, Giannopoulos NM, Contrafouris C, Bobos D, Kirvassilis GV, Sarris GE. Etiology and management of chylothorax following pediatric heart surgery. J Card Surg. 2009 Jul-Aug;24(4):369-73. doi: 10.1111/j.1540-8191.2008.00781.x. — View Citation
Orange JS, Geha RS, Bonilla FA. Acute chylothorax in children: selective retention of memory T cells and natural killer cells. J Pediatr. 2003 Aug;143(2):243-9. — View Citation
Sheeran T, Marvin RS, Pianta RC. Mothers' resolution of their child's diagnosis and self-reported measures of parenting stress, marital relations, and social support. J Pediatr Psychol. 1997 Apr;22(2):197-212. — View Citation
Staats BA, Ellefson RD, Budahn LL, Dines DE, Prakash UB, Offord K. The lipoprotein profile of chylous and nonchylous pleural effusions. Mayo Clin Proc. 1980 Nov;55(11):700-4. — View Citation
Suddaby EC, Schiller S. Management of chylothorax in children. Pediatr Nurs. 2004 Jul-Aug;30(4):290-5. Review. — View Citation
Wang CD, Chu PS, Mellen BG, Shenai JP. Creamatocrit and the nutrient composition of human milk. J Perinatol. 1999 Jul-Aug;19(5):343-6. — View Citation
* Note: There are 19 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To evaluate the time to resolution of chylothorax of infants receiving skimmed mother's milk versus specialized formula. | Fluid around the lungs is assessed by chest radiographs (x-rays) as per our usual standard of care. Cloudy fluid will be sent for analysis (chylomicrons, cell count, lymphocytes, and triglycerides) to confirm the diagnosis. The date of diagnosis, the date of chest tube removal, and the date of resolution of effusion by chest xrays | up to 2 months from enrollment | Yes |
| Secondary | To evaluate the recurrence rate of chylous effusion in infants receiving skimmed mother's milk versus specialized formula. | All patients receive a standard chest x-ray prior to discharge from the hospital and again in two weeks at their follow up appointment. If symptoms of respiratory difficulty occur prior to or following this time, additional chest x-rays may be obtained based on exam findings and clinical judgment. The date of recurrence of effusion will be recorded as will the date of chest tube insertion if required. | up to 4 months after hospital discharge | Yes |
| Secondary | To evaluate the technique of skimming and fortifying breast milk | The skimming technique will be taught to participating mothers and nurses caring for their infants. A sample of the skim milk will be analyzed by a creamatocrit for fat and caloric content. | the first 30 days after enrollment | Yes |
| Secondary | To compare feeding tolerance, growth, and nutrition in infants who receive fortified skimmed mother's milk versus specialized formula | Feeding symptoms observed by clinical staff and parents will be recorded. Parents will complete a questionnaire and score symptoms based on severity. Infants will be monitored as per our usual standard of care with weights, length measurements, and monitoring intake to ensure adequate growth | 2 months | No |