CONTEXT: Extremely low birth weight (ELBW) infants are prone to impaired neurodevelopment. OBJECTIVE: The aim was to determine long-term neurodevelopmental outcome in ELBW infants after postnatal 17β-estradiol (E2) and progesterone (P) replacement. DESIGN: At 5-yr corrected age, ELBW infants were assessed for standardized cognitive and neurological outcome after postnatal randomized E2 and P replacement or placebo administration. SETTING: The follow-up examination was performed in a neuropediatric ambulatory care center. PATIENTS: Sixty-one of 71 surviving infants (86%) were available for follow-up. MAIN OUTCOME MEASURES: Cognitive and neurological outcome was evaluated using the Kaufmann Assessment Battery for Children, the Gross Motor Function Classification Scale, and clinical neurological examination. RESULTS: No significant differences were found between the replacement and placebo groups for the Gross Motor Function Classification Scale, presence of paresis, cerebral palsy, spasticity, and ametropia. However, a significant time-response relationship was found with E2 and P replacement. Every day of treatment reduced the risk for cerebral palsy (P=0.03), spasticity (P=0.01), and ametropia (P=0.01). CONCLUSION: Postnatal E2 and P replacement may have potential in improving neurodevelopmental outcome in ELBW infants. Larger trials are needed to test this new hypothesis.
RCT Entities:
CONTEXT: Extremely low birth weight (ELBW) infants are prone to impaired neurodevelopment. OBJECTIVE: The aim was to determine long-term neurodevelopmental outcome in ELBW infants after postnatal 17β-estradiol (E2) and progesterone (P) replacement. DESIGN: At 5-yr corrected age, ELBW infants were assessed for standardized cognitive and neurological outcome after postnatal randomized E2 and P replacement or placebo administration. SETTING: The follow-up examination was performed in a neuropediatric ambulatory care center. PATIENTS: Sixty-one of 71 surviving infants (86%) were available for follow-up. MAIN OUTCOME MEASURES: Cognitive and neurological outcome was evaluated using the Kaufmann Assessment Battery for Children, the Gross Motor Function Classification Scale, and clinical neurological examination. RESULTS: No significant differences were found between the replacement and placebo groups for the Gross Motor Function Classification Scale, presence of paresis, cerebral palsy, spasticity, and ametropia. However, a significant time-response relationship was found with E2 and P replacement. Every day of treatment reduced the risk for cerebral palsy (P=0.03), spasticity (P=0.01), and ametropia (P=0.01). CONCLUSION: Postnatal E2 and P replacement may have potential in improving neurodevelopmental outcome in ELBW infants. Larger trials are needed to test this new hypothesis.
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