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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
Sponsor:
Information provided by (Responsible Party):
DR. VIKRAM DATTA, Lady Hardinge Medical College

Brief 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.


Condition or disease
Pre-Eclampsia

Show Show detailed description

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
late preterms from pre eclamptic mothers
late preterms born to pre eclamptic mothers
late preterms
late preterm neonates



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Incidence of small for gestational age babies. [ Time Frame: 22 MONTHS ]
    Incidence of small for gestational age babies.

  2. Need for NICU admission [ Time Frame: 22 MONTHS ]
    Need for NICU admission



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Ages Eligible for Study:   34 Weeks to 37 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

SAMPLE SIZE 60 intramural neonates divided in a group of 30 each. STUDY SUBJECTS Thirty late-preterm infants born to mothers with preeclampsia ---late preterms defined as infants born between 34 0/7 weeks and 36 6/7 weeks of gestation.

CONTROL SUBJECTS Thirty late preterm infants born to mothers without preeclampsia.

Criteria

INCLUSION CRITERIA

  • Late preterm infants
  • Pre eclampsia in mothers
  • Parental Consent

EXCLUSION CRITERIA

  • Major congenital malformation
  • Eclampsia ( seizures in mother)
  • Mothers on antipsychotic drugs
  • Clinical Chorioamnionitis ( fever > 100.4º F, uterine fundal tenderness, maternal tachycardia (>100/min), fetal tachycardia (>160/min) and purulent or foul amniotic fluid )
  • Birth Asphyxia (Apgar score of less than 7 at 1 minute of age)
  • Multiple gestation.

Information from the National Library of Medicine

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


Locations
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India
Lady Hardinge Medical College,New Delhi
Delhi, India
Sponsors and Collaborators
Lady Hardinge Medical College
Investigators
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Principal Investigator: vikram da datta, MD LHMC
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Responsible Party: DR. VIKRAM DATTA, DR VIKRAM DATTA, Lady Hardinge Medical College
ClinicalTrials.gov Identifier: NCT02443259    
Other Study ID Numbers: LHMC/ECHR/2014/165
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: March 2017
Keywords provided by DR. VIKRAM DATTA, Lady Hardinge Medical College:
NAPI
late preterm
Additional relevant MeSH terms:
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Eclampsia
Pre-Eclampsia
Pregnancy Complications
Hypertension, Pregnancy-Induced