Effect of Maternal Hemoglobin on Neurobehavioural Development of Late Preterm Neonates : A Cohort Study
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|ClinicalTrials.gov Identifier: NCT02840292|
Recruitment Status : Completed
First Posted : July 21, 2016
Last Update Posted : July 21, 2016
|Condition or disease|
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|
|Actual Enrollment :||100 participants|
|Official Title:||Effect of Maternal Hemoglobin on Neurobehavioural Development of Late Preterm Neonates : A Cohort Study|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||October 2014|
Late preterm neonates (>34weeks but <37weeks of gestation) with maternal hemoglobin < 11gm/dl
Late preterm neonates (>34weeks but <37weeks of gestation) with maternal haemoglobin ≥ 11gm/dl
- 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
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840292
|Lady Hardinge Medical College|
|New Delhi, Delhi, India, 110001|
|Study Chair:||Dr. Vikram Datta, MD, DNB||Lady Hardinge Medical College|
|Principal Investigator:||Dr. Sanya Chandna, MBBS||Lady Hardinge Medical College|