Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Magnetic Non-Invasive Acupuncture For Infant Comfort A Pilot Study in Preterm Infants Requiring Eye-exam for Retinopathy of Prematurity
Brief Summary: The purpose is to investigate whether non-invasive acupuncture - NIA (i.e. acupuncture without needles) will help reduce pain for babies in the Neonatal Intensive Care Unit (NICU) during their routine weekly eye-exam for Retinopathy of prematurity. Retinopathy of prematurity (ROP) is an eye disease most commonly affecting premature babies born weighing less than 1250 grams. Retinopathy of prematurity occurs because these premature babies require oxygen because of their immature lungs. The oxygen then stimulates the growth of blood vessels in the retina, causing the retina to be detached from the eye, which causes vision impairment.

To examine if the vessels grow at the back of the eye, an eye-doctor visits bi-weekly once the baby is 32 weeks corrected age to assess if the blood vessels change. If there is a lot of growth, the eye-doctor would use a laser to treat the eye to prevent further growth.

During the bi-weekly eye-exam, the premature infant receives sucrose (a type of sugar) for pain management. The investigator will assess pain a premature babies experience during this exam and found that there are extremely high scores of pain despite sucrose and the investigator believe this pain and stress caused by these procedures could be reduced by adding:

Magnetic Acupuncture

Also, untreated pain causes stress (lower oxygen levels, higher heart rates), discomfort and poorer long term outcomes.

Finding the best treatment and prevention for the pain caused by procedures in the NICU is therefore extremely important for any baby.


Options:
A: Arm Label: Group 1; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: Educational Video - Sham, Drug: Sucrose Placebo (water), Drug: Lidocaine Placebo | Arm Label: Group 2; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Educational video - Active, Drug: Sucrose Placebo (water), Drug: Lidocaine Placebo | Arm Label: Group 3; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Educational video - Active, Drug: Sucrose, Drug: Lidocaine Placebo | Arm Label: Group 4; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Educational video - Active, Drug: Sucrose, Drug: Lidocaine | Intervention Type: BEHAVIORAL; Name: Educational video - Active; Assigned to Arm(s): Group 2, Group 3, Group 4 | Intervention Type: BEHAVIORAL; Name: Educational Video - Sham; Assigned to Arm(s): Group 1 | Intervention Type: DRUG; Name: Sucrose Placebo (water); Assigned to Arm(s): Group 1, Group 2 | Intervention Type: DRUG; Name: Sucrose; Assigned to Arm(s): Group 3, Group 4 | Intervention Type: DRUG; Name: Lidocaine Placebo; Assigned to Arm(s): Group 1, Group 2, Group 3 | Intervention Type: DRUG; Name: Lidocaine; Assigned to Arm(s): Group 4
B: Arm Label: Intervention - Magnetic acupuncture; Type: EXPERIMENTAL; Interventions: Device: Magnetic acupuncture | Arm Label: Control - Placebo control; Type: PLACEBO_COMPARATOR; Interventions: Device: stickers (magnets removed) | Intervention Type: DEVICE; Name: Magnetic acupuncture; Assigned to Arm(s): Intervention - Magnetic acupuncture | Intervention Type: DEVICE; Name: stickers (magnets removed); Assigned to Arm(s): Control - Placebo control
C: Arm Label: A; Type: OTHER; Interventions: Other: aromatherapy massage | Arm Label: B; Type: OTHER; Interventions: Other: aromatherapy massage | Arm Label: C; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: aromatherapy massage; Assigned to Arm(s): A, B
D: Arm Label: Oral glucose solution + maternal holding; Type: EXPERIMENTAL; Interventions: Other: Oral glucose solution + maternal holding | Arm Label: Breastfeeding; Type: EXPERIMENTAL; Interventions: Other: Breastfeeding | Arm Label: Oral glucose solution; Type: ACTIVE_COMPARATOR; Interventions: Other: Oral glucose solution | Arm Label: Oral expressed breastmilk; Type: ACTIVE_COMPARATOR; Interventions: Other: Oral expressed breastmilk | Intervention Type: OTHER; Name: Oral glucose solution + maternal holding; Assigned to Arm(s): Oral glucose solution + maternal holding | Intervention Type: OTHER; Name: Breastfeeding; Assigned to Arm(s): Breastfeeding | Intervention Type: OTHER; Name: Oral glucose solution; Assigned to Arm(s): Oral glucose solution | Intervention Type: OTHER; Name: Oral expressed breastmilk; Assigned to Arm(s): Oral expressed breastmilk

Answer: B