Completed

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

What is being tested

Specialized Formula

+ Skimmed mother's milk

Other

Who is being recruted

+9 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: June 2012

See protocol details

Summary

Principal SponsorOregon Health and Science University

Last updated: October 14, 2015

Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01673165

Principal SponsorOregon Health and Science University

Last updated: October 14, 2015

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

17 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate

Be a breastfed or formula fed infant

Develop a chylous effusion

Infant birth to 12 months of age

Undergo cardiothoracic surgery

5 exclusion criteria prevent from participating

Infant born with congenital chylothorax

Infant in state custody (foster care)

Infant over 12 months of age

Infant who develops chylothorax from other surgeries (non-cardiac

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Active Comparator

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

Group II

Experimental

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Oregon Health and Science University - Doernbecher Children's Hospital

Portland, United StatesOpen Oregon Health and Science University - Doernbecher Children's Hospital in Google Maps

CompletedOne Study Center