Research: Dosage of Morphine for ill Newborns Still too Imprecise

LEIDEN, The Netherlands, December 22 - Dosage recommendations for newborns being cared for in an intensive care
unit will in the future most likely be based on more individual
characteristics than just body weight. This is the result of a study
conducted by the Dutch Top Institute Pharma in which Leiden University (Prof
M. Danhof) and the Rotterdam Erasmus Medical Centre/Sophia Children's
Hospital (Prof D. Tibboel) are represented.

Catherijne Knibbe, clinical pharmacologist from the Leiden/Amsterdam
Centre for Drug Research of Leiden University: "For morphine the preliminary
study results show that for example a quarter of the current standard dose is
sufficient for premature babies. The Erasmus MC/Sophia Children's Hospital
had already noted in practice that some babies experienced withdrawal
symptoms after long-term treatment with morphine. Now research has shown that
the required amount of morphine can vary greatly per baby."

The dosage for children is often adjusted solely according to body
weight, but that now seems to be insufficient. Knibbe said about the common
used sedative midazolam: "A healthy child may be prescribed far more
midazolam than for example a child with the same body weight lying in the
intensive care unit with a severe infection. This study provides guidelines
for arriving at a dosage recommendation that is adjusted better to the
individual child. This is an enormous advance." According to Knibbe, this
information is very important for doctors, as well as for pharmaceutical
companies, which have been required for the past two years to conform to
stricter European legislation for medicinal products for children.

This study required an intensive collaboration between clinical
pharmacologists and pediatricians from the various institutes using modern
methods like PK/PD modeling. Complex computer models can determine the
correct dosage from small quantities of blood, taking into account the
child's specific characteristics. Knibbe: "We know too little about the
effects of medicinal products on children, especially newborns. Although we
actually need more information than for adults. Children change so rapidly.
In the first year of life the child changes each week, and responds
differently and breaks down medicinal products differently. I think that
these study results will mean that in some cases children will receive less
medication, and thus fewer adverse effects will develop, while the child will
still be treated well. I consider that a major benefit: for doctors, but most
especially for the children and their parents."

The Top Institute Pharma is a collaboration between universities,
university medical centers and pharmaceutical companies. This intensive
collaboration accelerates research into new medicinal products and a better
use of medication. The Dutch Ministry of Public Health, Welfare and Sport
supports the Top Institute Pharma.

For more information, please contact Albert Reinders: +31-6-53184737.

For more information, please contact Albert Reinders: +31-6-53184737