Gastroschisis clinical trials

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Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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NCT ID: NCT01469208 Recruiting - Gastroschisis Clinical Trials

Music Therapy: An Adjunct To Gastroschisis Infants' Care

MAGIC

Start date: October 2011
Phase: N/A
Study type: Observational

The investigators hope to determine if music therapy will have beneficial effects on physiologic parameters, behavioral states, and pain scale evaluations in infants with gastroschisis defects and if music therapy promotes parental/caregiver relaxation and demonstrates to the parent/caregiver that music is an effective tool to calm and soothe their infant at risk for chronic gastrointestinal discomfort. Babies will be enrolled during the perinatal period, with therapy to begin after surgical repair of the gastroschisis defect and when the neonatologist deems the baby stable enough for music therapy intervention. Enrolled subjects may receive up to 3 music therapy sessions/week and these sessions may continue until discharge. There is no follow up after discharge. Each one hour session (20-30 minutes of music and 30 minutes of quiet) will include: 1. Pre music therapy behavior state will be assessed using CRIES scale and recorded. 2. Five minutes of baseline vital signs will be recorded. 3. Music therapy lasting 20-30 minutes, will start. Music therapist will use guitar and lap harp to perform live lullaby tupe music with or with out vocals. Decibel levels will be maintained at 65-75dB. Session will stop if infant shows any signs of distress/agitation. Vital signs will be collected every 1-4 minutes during music session. 4. After session behavior state using CRIES scale will be recorded. 5. Family/caregiver will be given a questionnaire to fill out. 6. 30 min of quiet will start. 7. At the end of quiet time, behavior state and vital signs will be recorded for the last time.