Trial Outcomes & Findings for Changes in Cerebral Oxygenation During Laparoscopic Pyloromyotomy (NCT NCT03650842)

Results Overview

Near-infrared spectroscopy (NIRS model INVOS 5100; Covidien, Minneapolis, MN, USA) with sensors (Neonate SomaSensor® CNN; Covidien, Minneapolis, MN, USA) placed on the forehead.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

At time of incision

Results posted on

2019-12-06

Participant Flow

Participant milestones

Participant milestones
Measure	Laparoscopic Pyloromyotomy Infants undergoing laparoscopic pyloromyotomy.
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Laparoscopic Pyloromyotomy n=25 Participants Patients undergoing laparoscopic pyloromyotomy.
Age, Continuous	40 days STANDARD_DEVIATION 10 • n=25 Participants
Sex: Female, Male Female	7 Participants n=25 Participants
Sex: Female, Male Male	18 Participants n=25 Participants
Region of Enrollment United States	25 participants n=25 Participants
Weight	4 kilograms STANDARD_DEVIATION 0.6 • n=25 Participants

PRIMARY outcome

Timeframe: At time of incision

Near-infrared spectroscopy (NIRS model INVOS 5100; Covidien, Minneapolis, MN, USA) with sensors (Neonate SomaSensor® CNN; Covidien, Minneapolis, MN, USA) placed on the forehead.

Outcome measures

Outcome measures
Measure	Laparoscopic Pyloromyotomy n=25 Participants Infants undergoing laparoscopic pyloromyotomy.
Cerebral Regional Oxygen Saturation (rSO2)	81 percentage of oxygen Standard Deviation 12

PRIMARY outcome

Timeframe: At the end of laparoscopy

Near-infrared spectroscopy (NIRS model INVOS 5100; Covidien, Minneapolis, MN, USA) with sensors (Neonate SomaSensor® CNN; Covidien, Minneapolis, MN, USA) placed on the forehead.

Outcome measures

Outcome measures
Measure	Laparoscopic Pyloromyotomy n=25 Participants Infants undergoing laparoscopic pyloromyotomy.
Cerebral Regional Oxygen Saturation (rSO2)	76 percentage of oxygen Standard Deviation 16

PRIMARY outcome

Timeframe: At time of incision

Near-infrared spectroscopy (NIRS model INVOS 5100; Covidien, Minneapolis, MN, USA) with sensors (Neonate SomaSensor® CNN; Covidien, Minneapolis, MN, USA) placed on the left posterior-lateral flank.

Outcome measures

Outcome measures
Measure	Laparoscopic Pyloromyotomy n=25 Participants Infants undergoing laparoscopic pyloromyotomy.
Renal Regional Oxygen Saturation (rSO2)	83 percentage of oxygen Standard Deviation 11

PRIMARY outcome

Timeframe: At the end of laparoscopy

Near-infrared spectroscopy (NIRS model INVOS 5100; Covidien, Minneapolis, MN, USA) with sensors (Neonate SomaSensor® CNN; Covidien, Minneapolis, MN, USA) placed on the left posterior-lateral flank.

Outcome measures

Outcome measures
Measure	Laparoscopic Pyloromyotomy n=25 Participants Infants undergoing laparoscopic pyloromyotomy.
Renal Regional Oxygen Saturation (rSO2)	77 percentage of oxygen Standard Deviation 20

Adverse Events

Laparoscopic Pyloromyotomy

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

Joseph D. Tobias, MD

Nationwide Children's Hospital

Phone: 614-722-5817

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place