Neurobehavioural Outcomes in Late Preterm Neonates (PRENB)
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|ClinicalTrials.gov Identifier: NCT02443259|
Recruitment Status : Completed
First Posted : May 13, 2015
Last Update Posted : March 7, 2017
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||60 participants|
|Official Title:||Short Term Neurobehavioural Outcomes in Late Preterm Neonates Born to Pre Eclamptic Mothers : a Prospective Observational Study|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
late preterms from pre eclamptic mothers
late preterms born to pre eclamptic mothers
late preterm neonates
- Neurobehavioral score by NAPI at 40 weeks of corrected gestation for MDV(Motor development- vigor) and AO(Alertness-orientation) [ Time Frame: 22 MONTHS ]Neurobehavioral score by NAPI at 40 weeks of corrected gestation for MDV(Motor development- vigor) and AO(Alertness-orientation)
- Incidence of small for gestational age babies. [ Time Frame: 22 MONTHS ]Incidence of small for gestational age babies.
- Need for NICU admission [ Time Frame: 22 MONTHS ]Need for NICU admission
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02443259
|Lady Hardinge Medical College,New Delhi|
|Principal Investigator:||vikram da datta, MD||LHMC|