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[Pharmacotherapy of psychomotor developmental delay in 6-12 months preterm infants with hypoxic-ischemic
N N Zavadenko1, V I Guzeva2, D D Gaynetdinova3
1Pirogov Russian National Research Medical University, Moscow, Russia.
Insights
Hopantenic acid (Pantogam) significantly improved psychomotor development in preterm infants with delays. This safe and effective treatment showed notable benefits in specific developmental domains for infants aged 6-12 months.
Area of Science:
- Neonatal neurology
- Developmental pediatrics
- Pharmacology
Background:
- Hypoxic-ischemic encephalopathy (HIE) is a major cause of psychomotor developmental delay in premature infants.
- Early intervention is crucial for improving long-term outcomes in affected infants.
- Hopantenic acid (Pantogam) is being investigated for its potential therapeutic effects in this population.
Purpose of the Study:
- To assess the efficacy and safety of hopantenic acid (Pantogam) as part of a comprehensive treatment strategy.
- To evaluate its impact on psychomotor developmental delay in prematurely born infants (6-12 months) following HIE.
- To compare outcomes between infants receiving Pantogam and those receiving a placebo.
Main Methods:
- A randomized controlled trial involving 87 prematurely born infants with psychomotor developmental delay due to HIE.
- Participants were assigned to receive either standardized treatment with Pantogam or standardized treatment with placebo for two months.
- Psychomotor development was assessed using the Griffiths Mental Development Scales (GMDS-ER) before and after the intervention period.
Main Results:
- A significantly higher percentage of infants (63.6%) in the Pantogam group showed improvement in developmental delay compared to the placebo group (36.4%) (p=0.021).
- Pantogam treatment led to significant improvements in 'Personal-Social' and 'Performance' domains, with a trend towards improvement in 'Locomotor', 'Hearing and Speech', and 'Eye and Hand Coordination'.
- Greater benefits were observed in late preterm infants (34-36 weeks gestation) compared to moderate preterm infants (32-33 weeks gestation). The safety profile was comparable to placebo.
Conclusions:
- Hopantenic acid (Pantogam) is an effective and safe medication for managing psychomotor developmental delay in preterm infants aged 6-12 months.
- It offers a valuable therapeutic option within a complex treatment regimen for infants affected by HIE.
- The study supports the use of Pantogam for improving neurodevelopmental outcomes in this vulnerable population.
Aim:
To evaluate the efficacy and safety of hopantenic acid (Pantogam) in the complex treatment of prematurely born infants, aged 6-12 months, with psychomotor developmental delay due to hypoxic-ischemic encephalopathy.
Material And Methods:
Eighty-seven patients were randomized into two groups: 44 received standardized treatment and pantogam for two months, 43 standardized treatment and placebo. Pantogam (syrup 100 mg/ml) or placebo were prescribed orally 15-30 minutes after feeding, twice a day, in a daily dosage of 30-50 mg/kg body weight. The assessment of psychomotor development from birth to two years was performed with the Griffiths Mental Development Scales (GMDS-ER) twice (before and after completion of therapy).
Results:
The response to two month therapy determined as the reduction of developmental delay for more than 6% of the initial GMDS-ER general quotient (GQ) score was significantly better in the group I after pantogam treatment (63.6% of patients) compared to group II (36.4%, p=0.021). Group I demonstrated the significant decrease of the developmental delay in two domains ('Personal-Social' and 'Performance') and a trend to overcome the delay in three other domains: 'Locomotor', 'Hearing and Speech', 'Eye and Hand Coordination'. The improvement after pantogam treatment was more obvious in the subgroup of infants born late preterm (gestational age 34-36 weeks) compared to infants born moderate preterm (gestational age 32-33 weeks). The favorable safety profile of pantogam was confirmed, comparable to that of placebo.
Conclusion:
Pantogam is efficient and safe medication in the complex treatment of psychomotor developmental delay in preterm infants, aged 6-12 months.
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