Clinical trial NCT02840292: Effect of Maternal Hemoglobin on Neurobehavioural Development of Late Preterm Neonates : A Cohort Study
Official title: Effect of Maternal Hemoglobin on Neurobehavioural Development of Late Preterm Neonates : A Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Keywords: Late Preterms
Neurobehavioral Assessment of Preterm Infants (NAPI)
Lead sponsor: Lady Hardinge Medical College
Sponsor class: OTHER_GOV
First posted: 2016-07-21
Enrollment: 100
Sex: ALL
Minimum age (years): 34
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of neurobehavioral development
timeFrame: 2 months
Secondary outcomes:
measure: Comparison of NAPI Score
timeFrame: 1 month
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Lady Hardinge Medical College
state: Delhi
Study officials:
affiliation: Lady Hardinge Medical College
name: Dr. Vikram Datta, MD, DNB
role: STUDY_CHAIR
affiliation: Lady Hardinge Medical College
name: Dr. Sanya Chandna, MBBS
role: PRINCIPAL_INVESTIGATOR
References: