Clinical trial NCT01673165: Fortified Skimmed Mother's Milk in the Management of Chylothorax
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chylous Pleural Effusion Following Cardiothoracic Surgery
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: The Gerber Foundation
First posted: 2012-08-27
Enrollment: 17
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: A chylothorax is a collection of fluid around the lungs that can occur after cardiac surgery. The fluid contains chyle, a milky fluid consisting of fat droplets. The standard treatment is to feed an infant with a specialized low fat formula for up to 6 weeks until the chest has time to heal. This formula is generally not well tolerated and mother's of our patients have expressed a desire to continue using breast milk. A few case reports have been published, but there have not been any studies to date looking at this. Data will be collected to include information about nutrition, weight gain, teaching needs, surgical, hospital, and discharge information.

Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the time to resolution of chylothorax of infants receiving skimmed mother's milk versus specialized formula.
timeFrame: up to 2 months from enrollment
Secondary outcomes:
measure: To evaluate the recurrence rate of chylous effusion in infants receiving skimmed mother's milk versus specialized formula.
timeFrame: up to 4 months after hospital discharge
measure: To evaluate the technique of skimming and fortifying breast milk
timeFrame: the first 30 days after enrollment
measure: To compare feeding tolerance, growth, and nutrition in infants who receive fortified skimmed mother's milk versus specialized formula
timeFrame: 2 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University - Doernbecher Children's Hospital
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Cindi Farnstrom, MN, CPNP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Le Coultre C, Oberhansli 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. doi: 10.1016/0022-3468(91)90696-q.
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.
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. doi: 10.1016/j.athoracsur.2005.04.048.
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. doi: 10.1067/mpd.2000.104287.
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. doi: 10.1016/0003-4975(93)90881-h.
citation: Suddaby EC, Schiller S. Management of chylothorax in children. Pediatr Nurs. 2004 Jul-Aug;30(4):290-5.
citation: 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. doi: 10.1016/0022-3468(91)90325-n.
citation: Lessen R. Use of skim breast milk for an infant with chylothorax. ICAN: Infant, Child, & Adolescent Nutrition. 2009; 1(6):303-310.
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. doi: 10.1038/sj.jp.7211768. Epub 2007 Jun 7.
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.
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. doi: 10.1016/s0003-4975(03)01189-5.
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. doi: 10.1067/S0022-3476(03)00305-6.
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. doi: 10.1093/jpepsy/22.2.197.
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. doi: 10.1038/sj.jp.7200204.
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.
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. doi: 10.1136/bmj.1.6119.1018.
citation: Buttiker V, Fanconi S, Burger R. Chylothorax in children: guidelines for diagnosis and management. Chest. 1999 Sep;116(3):682-7. doi: 10.1378/chest.116.3.682.
citation: 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. doi: 10.1097/00005650-198603000-00003.
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.