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Neurobehavioural Outcomes in Late Preterm Neonates

NCT02443259 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2017-03-07

No results posted yet for this study

Summary

Hypertensive disorders are the most common medical complications in pregnancy and major causes of maternal, fetal, and neonatal morbidity and mortality. Fifty percent of hypertensive disorders of pregnancy are defined as pre eclampsia, the most important manifestation of the disease.

Preeclampsia is also a significant risk factor in the development of IUGR and represents the most common cause of IUGR in the nonanomalous infant. The incidence of thrombocytopenia, neutropenia and Bronchopulmonary dysplasia is also increased in neonates with preeclampsia.

The neurodevelopmental outcomes infants exposed to preeclampsia are highly variable. The study by Gray et al showed that preeclampsia is associated with a decreased risk of cerebral palsy. They also found a protective effect of maternal preeclampsia on cerebral palsy regardless of exposure to magnesium sulfate. However, contrary to this, study conducted by Shao-Wen Cheng et al has showed that infants born to pre-eclamptic mothers had lower MDI scores at 24 months of age (P= 0.04) as compared to infants without maternal pre-eclampsia. The study by Szymonowicz et al showed that neonates born to pre-eclamptic mothers had a significantly lower mean mental developmental index, and significantly more of these children had one or more impairments compared with the control group at 2 years of age. The neurodevelopmental outcomes in neonates born to preeclamptic mothers therefore remain inconclusive. Recently the role of neurobehaviour being evaluated early at 37-40 weeks of CGA is being predicted as an useful adjunct to the 12-18 month full neurodevelopmental assessment. This assumes significance in the context of initiation of early stimulation and objectivised individual developmental rehabilitation regimens for these infants.

Conditions

  • Pre-Eclampsia

Sponsors & Collaborators

  • Lady Hardinge Medical College

    lead OTHER_GOV

Principal Investigators

  • vikram da datta, MD · LHMC

Eligibility

Min Age
34 Weeks
Max Age
37 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02443259 on ClinicalTrials.gov