Neurobehavioural Outcomes in Late Preterm Neonates

NCT02443259 | Completed

• 1 other identifier: LHMC/ECHR/2014/165
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-Eclampsia

Keywords

NAPI; late preterm

Outcome Measures

Primary Outcomes (1)

• Neurobehavioral score by NAPI at 40 weeks of corrected gestation for MDV(Motor development- vigor) and AO(Alertness-orientation)

  Neurobehavioral score by NAPI at 40 weeks of corrected gestation for MDV(Motor development- vigor) and AO(Alertness-orientation)

  22 MONTHS

Secondary Outcomes (2)

• Incidence of small for gestational age babies.

  22 MONTHS

• Need for NICU admission

  22 MONTHS

Study Arms (2)

late preterms from pre eclamptic mothers

late preterms born to pre eclamptic mothers

late preterms

late preterm neonates

Eligibility Criteria

• Age: 34 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lady Hardinge Medical College: lead

Study Sites (1)

Lady Hardinge Medical College,New Delhi

Delhi, India

Location

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• vikram da datta, MD

  LHMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR VIKRAM DATTA

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: May 13, 2015
• Study Start: January 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: March 7, 2017

Record last verified: 2017-03

Locations

IN (1)