A clinical trial to study the effect of Early Intervention on Neurodevelopment in Preterm Infants

Not Applicable

Registration Number: CTRI/2019/07/020291

Lead Sponsor: Alice Jeba J

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Both sex born at 28 to < 37 weeks of gestation.

2. Birth weight of 1000gms -2500gms within the first 48 hours.

3. Apgar score > 7 at 1st and 5th minute with no resuscitation required at birth.

4. Infants who are medically stable with medical conditions primarily related to immaturity such as elevated bilirubin and mild hypoglycemia and hypocalcemia.

Exclusion Criteria

1. Premature infants with genetic and congenital anomalies.

2. Any infections, such as, HIV, syphilis, hepatitis B, septicemia and intracranial.

3. IUGR, Hypothyroidism, inborn errors of metabolism

4. Any evidence of intraventricular hemorrhage/ central nervous system dysfunction.

5. Maternal history of high blood pressure, diabetes.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eurodevelopment by the end of first year of lifeTimepoint: Neurodevelopment by the end of 3rd, 6th, 9th and 12th month of the baby.

Secondary Outcome Measures

Name	Time	Method
eurological Maturity <br/ ><br>Weight Gain <br/ ><br>Feeding Transition Duration <br/ ><br>Physiological Parameters( Temperature, Heart Rate, Respiratory Rate, Oxygen Saturation). <br/ ><br>Timepoint: Neurological Maturity- after 40 weeks of Gestational Age <br/ ><br>Weight Gain- after 10 days of treatment <br/ ><br>Feeding Transition duration- number of days necessary to make the transition from complete tube feeding to independent eight oral feeding for 2 consecutive days <br/ ><br>Physiological Parameters-after 5 days of treatment.