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

July 19, 2016 updated by: DR. VIKRAM DATTA, Lady Hardinge Medical College
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.

Study Overview

Status

Completed

Conditions

Detailed Description

Prevalence of anemia in India is among the highest in the world. A high proportion of women in both industrialized and developing countries become anemic during pregnancy. The major concern about the adverse effects of anemia on pregnant women and their offsprings is the belief that this population is at a greater risk of perinatal mortality and morbidity. Apart from this, it is well known that anemia per se is associated with higher incidence of premature births and low birth weight babies. Infants with iron deficiency anemia have significantly lower motor and mental scores and decreased language capabilities and body balance-coordination skills. Such infants also have a decreased learning ability. Iron deficiency anemia during the developmental stage can lead to reduced myelination of the spinal cord, as well as a change in myelin composition; abnormalities in neurotransmitters' metabolism and alteration in brain energy metabolism. The Neurobehavioral Assessments of Preterm Infants (NAPI) is a research tool to monitor the developmental progress and differential maturity of preterm infants ranging between 32weeks and 37weeks (full term). This test is used to identify persistent lags in development, as a research tool to assess effects of interventions and to study individual differences and basic developmental questions. The reliability and clinical validity of this test has been thoroughly investigated and normative data has been established.

Objective - To evaluate the neurobehavioral development at 37weeks of post conceptional age in late preterm infants born to mothers with hemoglobin <11gm/dl; by a standardised scale - Neurobehavioral Assessment of Preterm Infants (NAPI).

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110001
        • Lady Hardinge Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 months to 8 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of neurobehavioral development
Time Frame: 2 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of NAPI Score
Time Frame: 1 month
The scores of the two sub domains of Neurobehavioral Assessment of Preterm Infants (NAPI) i.e. Motor Development and Vigor (MDV) and Alertness and Orientations (AO) were compared to determine the level of maturity in the neurobehavioral development in cases and controls.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lady Hardinge Medical College

Investigators

  • Study Chair: Dr. Vikram Datta, MD, DNB, Lady Hardinge Medical College
  • Principal Investigator: Dr. Sanya Chandna, MBBS, Lady Hardinge Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

July 19, 2016

First Submitted That Met QC Criteria

July 19, 2016

First Posted (Estimate)

July 21, 2016

Study Record Updates

Last Update Posted (Estimate)

July 21, 2016

Last Update Submitted That Met QC Criteria

July 19, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hemoglobin and Neurobehaviour

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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