Linear Growth and Neurobehavioural Outcome in PT Neonates (<34 Wks) at 37 and 40 Wks of CGA

NCT02970994 | Completed DMC

• 1 other identifier: LadyHardinge MC
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate the association of linear growth on neurobehavioural outcome in preterm neonates at 37 and 40 weeks of (CGA) corrected gestational age.

Conditions

PreTerm Birth

Keywords

Linear growth and neurodevelopment outcome; < 34 weeks

Outcome Measures

Primary Outcomes (1)

• Association of linear growth on neurobehavioural outcome in preterm neonates

  All preterm neonates born in LHMC who meet the inclusion criteria will be included in the study with in 48 hours of admission .Demographic data, maternal history, labour details and neonatal details will be recorded in the proforma. Length will be measured using a flexible tape measuring tape and a standard infant length board to the nearest 0.1 cm . Length will be measured at time of enrolment,at time of discharge,at 37 weeks and 40 weeks of corrected gestational age.Standardized Z-scores will be calculated for the length and using reference data which included Fenton curves at birth and hospital discharge. Neonates will be evaluated by NAPI score at 37 weeks and 40 weeks of corrected gestational age for neurobehavioural assessment.

  18 months

Study Arms (1)

Preterm neonates <34 wks

Haemodynamicaly stable preterm neonates \<34 weeks with in 48 hours of admission

Eligibility Criteria

• Age: 1 Day - 40 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Haemodynamicaly stable preterm neonates \<34 weeks with in 48 hours of admission

You may qualify if:

• Preterm infants ( Haemodynamicaly stable preterm neonates \<34 weeks with in 48 hours of admission )
• Parental Consent

You may not qualify if:

• Major congenital malformation
• Haemodynamic instability
• Birth asphyxia(Apgar score of less than 7 at 1 minute of age)
• Multiple gestation.
• IVH
• Meningitis
• Hypoglycemia at admission

Sponsors & Collaborators

• Lady Hardinge Medical College: lead

Related Publications (1)

• Pfister KM, Ramel SE. Linear growth and neurodevelopmental outcomes. Clin Perinatol. 2014 Jun;41(2):309-21. doi: 10.1016/j.clp.2014.02.004. Epub 2014 Apr 14.

  PMID: 24873834 RESULT

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Vikram Datta, MD,DNB

  Lady Hardinge Medical College,New Delhi,Delhi,INDIA,110001.

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 12, 2016
• First Posted: November 22, 2016
• Study Start: January 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 17, 2017

Record last verified: 2017-03