Trial Outcomes & Findings for Proparacaine and Mydriatic Eye Drops (NCT NCT01266824)

Results Overview

Comparison of the change in Premature Infant Pain Profile (PIPP) scores from baseline to the time immediately following mydriatic drop administration between the groups of infants who do and do not receive Proparacaine eye drops prior to mydriatic drops. The PIPP score is a scale to determined pain response that was designed for use in preterm and term infants. It is based on both physiologic and behavioral changes exhibited by infants during the study period of 30s (facial changes, HR, O2 saturation). There are correction factors for gestational age and baseline state at time of scoring. Scores can range from 0-21 with the maximum score dependent on the infant's gestational age. A score \>7 typically indicates a pain response while a score \>12 indicates more severe pain.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

Change from baseline to time immediately following mydriatic drop administration

Results posted on

2013-03-19

Participant Flow

Recruitment for this study was terminated due to poor enrollment.

Participant milestones

Participant milestones
Measure	Proparacaine Infants in this group will receive 1 drop of Proparacaine (anesthetic eye drop) into each eye prior to receiving mydriatic eye drops Proparacaine Hydrochloride Ophthalmic Solution : 1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops	Standard of Care Infants in this arm will not receive Proparacaine (anesthetic eye drop) prior to mydriatic eye drops.
Overall Study STARTED	2	3
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Proparacaine Infants in this group will receive 1 drop of Proparacaine (anesthetic eye drop) into each eye prior to receiving mydriatic eye drops Proparacaine Hydrochloride Ophthalmic Solution : 1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops	Standard of Care Infants in this arm will not receive Proparacaine (anesthetic eye drop) prior to mydriatic eye drops.
Overall Study Study terminated prior to completion	2	3

Baseline Characteristics

Proparacaine and Mydriatic Eye Drops

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Proparacaine n=2 Participants Infants in this group will receive 1 drop of Proparacaine (anesthetic eye drop) into each eye prior to receiving mydriatic eye drops Proparacaine Hydrochloride Ophthalmic Solution : 1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops	Standard of Care n=3 Participants Infants in this arm will not receive Proparacaine (anesthetic eye drop) prior to mydriatic eye drops.	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	0.14 years STANDARD_DEVIATION 0.028 • n=5 Participants	0.12 years STANDARD_DEVIATION 0.006 • n=7 Participants	0.13 years STANDARD_DEVIATION 0.016 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline to time immediately following mydriatic drop administration

Population: Due to poor enrollment, this study was not completed and no patients were analyzed as a part of the randomized controlled trial.

Comparison of the change in Premature Infant Pain Profile (PIPP) scores from baseline to the time immediately following mydriatic drop administration between the groups of infants who do and do not receive Proparacaine eye drops prior to mydriatic drops. The PIPP score is a scale to determined pain response that was designed for use in preterm and term infants. It is based on both physiologic and behavioral changes exhibited by infants during the study period of 30s (facial changes, HR, O2 saturation). There are correction factors for gestational age and baseline state at time of scoring. Scores can range from 0-21 with the maximum score dependent on the infant's gestational age. A score \>7 typically indicates a pain response while a score \>12 indicates more severe pain.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within 5 minutes after Proparacaine administration

Population: Due to poor enrollment, this study was not completed and no patients were analyzed as a part of the randomized controlled trial.

PIPP scores measure immediately after Proparacaine administration

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within 5 minutes after Proparacaine/mydriatic drop administration until study monitor disconnected

Population: Due to poor enrollment, this study was not completed and no patients were analyzed as a part of the randomized controlled trial.

Number of episodes of bradycardia (HR 90) and significant desaturation (event requiring stimulation, per Neonatal Intensive Care Unit (NICU) protocol, to resolve) occurring after the administration of mydriatic and proparacaine eye drops

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within 5 minutes after Mydriatic drop administration

Population: Due to poor enrollment, this study was not completed and no patients were analyzed as a part of the randomized controlled trial.

PIPP score measure immediately following mydriatic drop administration

Outcome measures

Outcome data not reported

Adverse Events

Proparacaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Amy Cohen

Children's Hospital of Philadelphia

Phone: 215-590-1000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place