None listed
Conditions
Interventions
None listed
Sponsors
Marico Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: Full term (born after 37 weeks of gestation) and preterm (born prematurely prior to 37 weeks gestation), either normal or C-Section, neonates (till the age of 28 days) weighing 2500 grams at the time of recruitment or more will be included if they fulfill the following inclusion criteria: 1. Apgar score >7 at 1 and 5 minutes with no resuscitation required at birth. 2. Medically stable with no requirement of drugs, or any interventions/procedures other than Nutraceuitcal / health supplement. 3. Parents of the babies willing to sign an informed consent
Exclusion criteria
Exclusion criteria: 1. Neonates not on breast feed 2. Sick babies and those babies who have congenital anomalies or neuromuscular disorders. 3. Babies with muscular trauma or skin infections. 4. Parents of the Babies not willing to come for follow-up when required 5. Babies participating in any other clinical trials. 6. Known hypersensitivity to any of the ingredients of study product 7. Other conditions, which in the opinion of the investigators, make subject unsuitable for enrolment or could interfere with his/her participation in, and completion of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in anthropometrical measurements from baseline to each follow visit and against control. 2. Changes in Z score from baseline to each follow visit and against control Timepoint: Screening/ Baseline visit (Day 0), Visit 1 (Day 15), Visit 2 (Day 30), Visit 3 (Day 45), Visit 4 (Day 60), Visit 5 (Day 75), Visit 6 (Day 90) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in orientation state, effect on mood, activity status, cooperation for massage and fidgeting/nervous behavior of subjects prior to massage, during massage and post massage 2. Changes in sleep pattern 3. Changes in Softness / suppleness / smoothness of skin 4. Changes in muscle and bone strength 5. Time taken for major milestones 6. Changes in food intake on 7. Changes in episodes, severity and duration of illness (infections or allergies) 8. Changes in skin condition. 9. Overall change in growth and behavior by investigator and parents / legal guardian 10. Assessment of adverse events and vitals 11. Tolerability of oil massage as per the parents / legal guardian and investigator Timepoint: Screening/ Baseline visit (Day 0), Visit 1 (Day 15), Visit 2 (Day 30), Visit 3 (Day 45), Visit 4 (Day 60), Visit 5 (Day 75), Visit 6 (Day 90) | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research Pvt. Ltd
Outcome results
None listed