Effect of Maternal Hemoglobin on Neurobehavioural Development of Late Preterm Neonates : A Cohort Study

NCT02840292 | Completed DMC

• 1 other identifier: Hemoglobin and Neurobehaviour
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The study entitled 'Effect of maternal hemoglobin on neurobehavioral development of late preterm neonates' was done with an objective to determine whether low maternal hemoglobin (\<11gm/dl), in late preterm neonates(\>34weeks but less than 37weeks gestational age) correlates with poor neurobehavioral outcome using the Neurobehavioral Assessment of Preterm Infants(NAPI) tool, thereby allowing for earlier rehabilitative intervention to be undertaken to improve their long term outcomes and to generate useful data on a previously well recognised but under researched entity.

Conditions

Anemia

Keywords

Late Preterms; Neurobehavioral Assessment of Preterm Infants (NAPI)

Outcome Measures

Primary Outcomes (1)

• Evaluation of neurobehavioral development

  The two sub domains of Neurobehavioral Assessment of Preterm Infants (NAPI) i.e. Motor Development and Vigor (MDV) and Alertness and Orientations (AO) were tested to evaluate the neurobehavioral development at 37weeks of post conceptional age in late preterm neonates

  2 months

Secondary Outcomes (1)

• Comparison of NAPI Score

  1 month

Study Arms (2)

Cases

Late preterm neonates (\>34weeks but \<37weeks of gestation) with maternal hemoglobin \< 11gm/dl

Controls

Late preterm neonates (\>34weeks but \<37weeks of gestation) with maternal haemoglobin ≥ 11gm/dl

Eligibility Criteria

• Age: 34 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

100 late preterms (56 cases vs. 44 controls) fulfilling the criteria were enrolled from Main Labor Room, Maternity Ward, Operation Theatre or Post Natal Wards of the Department of Obstetrics and Gynaecology, Lady Hardinge Medical College. NAPI was administerd to 63 neonates (32 cases vs 31 controls).

You may qualify if:

• Late preterm infants born to mothers \<35yrs of age and born between 34weeks to 36.6weeks of gestation as calculated by last menstrual period/1st trimester ultrasound
• Clinically stable from respiratory, hemodynamic and metabolic point of view
• After receiving full, free, voluntary, informed consent from parents/family members within 24 hours of delivery.

You may not qualify if:

• Chorioamnionitis in pregnancy.
• Congenital malformations (antenatally diagnosed or evident on clinical examination)
• Neonates admitted to NICU
• Neonates requiring ventilator support
• Neonates with any neurological impairment (IVH etc)
• Neonates undergoing surgery
• Neonates with birth asphyxia
• Neonates with birth trauma
• Confirmed history of substance abuse in mother.

Sponsors & Collaborators

• Lady Hardinge Medical College: lead

Study Sites (1)

Lady Hardinge Medical College

New Delhi, National Capital Territory of Delhi, 110001, India

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Dr. Vikram Datta, MD, DNB

  Lady Hardinge Medical College

  STUDY CHAIR

• Dr. Sanya Chandna, MBBS

  Lady Hardinge Medical College

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: July 21, 2016
• Study Start: June 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: July 21, 2016

Record last verified: 2016-07

Locations

IN (1)