Cerebral Palsy Clinical Trial
Official title:
Randomized Clinical Trial of the Beneficial Effects of Antenatal Magnesium Sulfate (BEAM)
As many more premature infants survive, the numbers of these infants with health problems increases. The rate of cerebral palsy (CP) in extremely premature infants is approximately 20%. Magnesium sulfate, the most commonly used drug in the US to stop premature labor, may prevent CP. This trial tests whether magnesium sulfate given to a woman in labor with a premature fetus (24 to 31 weeks out of 40) will reduce the rate of death or moderate to severe CP in the children at 2 years. The children receive ultrasounds of their brains as infants and attend three follow-up visits over two years to assess their health and development.
The prevalence of cerebral palsy is increasing as the survival rate of extremely premature
infants is improving. Studies have suggested an apparent association between maternal
magnesium sulfate administration and a reduced risk of cerebral palsy. Other studies have
suggested a possible association between magnesium sulfate and a reduction in neonatal
cranial ultrasound abnormalities which may be markers for subsequent development of cerebral
palsy.
This multicenter trial tests whether prophylactic magnesium sulfate given to women, for whom
preterm delivery is imminent, reduces the risk of death or moderate to severe cerebral palsy
in their children. Women presenting from 24.0 to 31.6 weeks gestation with advanced preterm
labor or premature rupture of the membranes (pPROM) and no recent exposure to magnesium
sulfate are randomized to receive either intravenous magnesium sulfate or masked study drug
placebo. The study drug is administered as a 6 gram loading dose followed by a 2 gram/hour
infusion (or equivalent rate for placebo). If after 12 hours, delivery has not occurred and
is not anticipated, the infusion is stopped. No other parenteral tocolytics other than the IV
medication may be used. Retreatment with study medication is given any time labor recurs or
delivery is anticipated until gestational age is > 34.0 wks. Standard clinical management and
therapy is to be maintained for all study patients. Patients are assessed for signs of
intolerance to the study medications and maternal data are collected up to hospital
discharge. A sample of venous blood is collected and neonatal cranial ultrasounds are
performed. Up to three follow-up visits are scheduled over two years where certified
examiners, masked to study group assignment, collect physical and neurological data,
including a modified Gross Motor Function Classification Scale. The Bayley Scales of Infant
Development is also administered. Cranial ultrasounds are reviewed centrally.
The primary outcome is a composite outcome of death or moderate to severe cerebral palsy.
Secondary outcomes include maternal infectious morbidity, pulmonary edema and placental
abruption, neonatal stillbirth and death, intraventricular hemorrhage, periventricular
leukomalacia, neonatal infectious and noninfectious morbidity.
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