Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-24 @ 7:59 PM
NCT ID:
NCT00949104
Eligibility Criteria:
Inclusion Criteria:
* All pre-terms ( \< 37 weeks of gestational age.)
* Within the first 7 days postnatal days (\</=168 hours).
* Clinically stable from respiratory, hemodynamic and metabolic point of view.
* Who have not received any painful stimulus at least 30 minutes prior to the intervention.
* Requiring routine orogastric tube insertion within the first 7 days of life.
* Only the first attempt at putting OGT in controlled NICU environment will be considered
Exclusion Criteria:
The neonates with the following characteristics will be excluded from the study:
* Neonates requiring ventilatory support.
* Neonates requiring oxygen supplementation.
* Having any facial congenital anomalies.
* Having any neurological impairment.
* Receiving opiates or born to mothers receiving opiates.
* New born babies to whom muscle relaxants, sedatives and analgesics have been administered.
* With grade 3 and 4 IVH.
* With major congenital anomalies
* Any history of birth trauma especially involving face or scalp (including cephalhematoma/ subgaleal bleed).
* Face presentation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Hour
Maximum Age:
167 Hours
Study:
NCT00949104
Study Brief:
Protocol Section:
NCT00949104