Fortified Skimmed Mother's Milk in the Management of Chylothorax

Oregon Health & Science University (OHSU)

Status: Completed

Conditions: Chylous Pleural Effusion Following Cardiothoracic Surgery

Treatments: Other: Specialized Formula; Other: Skimmed mother's milk

Study type: Interventional

Funder types: Other

Identifiers

NCT01673165

Gerber7747

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 1 day to 12 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

Specialized Formula

Active Comparator group

Description:

25 infants of mothers who do not have breast milk or do not want to use the skimming technique. These infants will receive our standard of care - specialized formula for the treatment of chylothorax

Treatment:

Other: Specialized Formula

Skimmed mother's milk

Experimental group

Description:

25 infants of mothers who have breast milk and who also want to learn the skimming technique will be taught the technique. The infants will then receive the skimmed breast milk for the treatment of chylothorax

Treatment:

Other: Skimmed mother's milk