Skip to content

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

Effect of Early Intervention on Neurodevelopment in Preterm Infants

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/07/020291
Enrollment
96
Registered
2019-07-22
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Early Intervention: Tactile, Kinesthetic, Oromotor, Vestibular Auditory Stimulation and Positioning (Nesting) will be given for half an hour twice a day by the principal investigator. a

Sponsors

Alice Jeba J
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Both sex born at 28 to 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

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.

Design outcomes

Primary

MeasureTime frame
Neurodevelopment by the end of first year of lifeTimepoint: Neurodevelopment by the end of 3rd, 6th, 9th and 12th month of the baby.

Secondary

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

Countries

India

Contacts

Public ContactAlice Jeba J

Department of Physiotherapy, NRR Hospital

dralicejeba@yahoo.co.in91-7204143730

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026