Effect of Early L-Carnitine Supplementation on Neurodevelopmental Outcomes in Very Preterm Infants

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test L-Carnitine.

Without supplementation, almost all preterm infants develop carnitine deficiency soon after birth.

It had two arms (groups): one (placebo comparator) and L-carnitine (experimental).

The registry classes the interventions as drug.

More on the Plan

Methods/Design: This is a prospective, randomized controlled clinical trial involving infants with gestational age (GA) \<32 wks who are born at either the Jack D.

Informed consent will be obtained from the parents of eligible patients as early as possible within 72 hours of birth.

Because gestational age and small for gestational age (SGA) status will impact their outcome measures, the researchers will ensure they are equally distributed in the arms of the study by stratifying based upon these variables.

The researchers will analyze the two study arms using an intent-to-treat analysis.

Who Took Part

144 actual participants took part.

It was open to people of any sex aged from 1 Day up to 3 Days.

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: critically ill infants with life expectancy less than 72 hours; inability to obtain consent within 72 hours of birth; potentially life-threatening congenital anomalies.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Because people in this L-Carnitine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on L-Carnitine, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2013-01 with completion listed for 2020-12.

It ran at 2 sites in United States (2).

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Time to Regain Birthweight in Infants Who Receive L-carnitine Supplementation Compared to Controls (time frame: up to 3 weeks of age). Neurodevelopment Indices in Infants Who Receive L-carnitine Supplementation Compared to Controls (NNNS) (time frame: at term equivalent age (38 weeks +/-1 week corrected age)).

It also tracked 2 secondary outcomes, for example Brain Volumes in Infants Who Received L-carnitine Supplementation Compared to Controls and Rate of Head Growth in Infants Who Receive L-carnitine Supplementation Compared to Controls.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of L-Carnitine in 144 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the L-Carnitine compound page, all human trials.