Trial Outcomes & Findings for Intra-Abdominal Hypertension in Neonatal Intensive Care Patients (NCT NCT00747552)

Results Overview

Intra-abdominal Pressure (IAP) measurements were taken using an electronic pressure transducer via an indwelling urinary catheter. Measurements were obtained every 2-4 hours while the urinary catheter remained in place. This will be used to determine feasability of using a urinary catheter and electronic pressure transducer system to determine IAP. A total of 1219 measurements were obtained from 30 subjects.

Recruitment status

COMPLETED

Target enrollment

30 participants

Primary outcome timeframe

3 years

Results posted on

2010-01-26

Participant Flow

From Jan 2006 to Apr 2008, 32 infants who were inpatients in NICU were enrolled into the study.

2 of the infants that were enrolled had the urinary catheter removed prior to any data collection. As the presence of a urinary catheter is necessary for bladder measurements, no data was able to be collected and therefore never actually started in the study.

Participant milestones

Participant milestones
Measure	Infants With Urinary Catheter in Place Any infant admitted to the NICU who requires an indwelling urinary catheter as part of their illness will qualify for this study. This group will be further analyzed based on whether their illness is due to abdominal abnormalities or disease or whether there is another serious illness requiring an indwelling urinary catheter. The group will also be analyzed pre and post-operatively.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intra-Abdominal Hypertension in Neonatal Intensive Care Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Infants With Urinary Catheter in Place n=30 Participants Any infant admitted to the NICU who requires an indwelling urinary catheter as part of their illness will qualify for this study. This group will be further analyzed based on whether their illness is due to abdominal abnormalities or disease or whether there is another serious illness requiring an indwelling urinary catheter. The group will also be analyzed pre and post-operatively.
Age, Categorical <=18 years	30 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years

Population: 18 of the neonates required staged abdominal surgery for various abdominal abnormalities or disease, while 12 of the neonates were ill due to PPHN, sepsis, or hydrops. All analysis was per protocol.

Intra-abdominal Pressure (IAP) measurements were taken using an electronic pressure transducer via an indwelling urinary catheter. Measurements were obtained every 2-4 hours while the urinary catheter remained in place. This will be used to determine feasability of using a urinary catheter and electronic pressure transducer system to determine IAP. A total of 1219 measurements were obtained from 30 subjects.

Outcome measures

Outcome measures
Measure	Infants With Urinary Catheter in Place n=30 Participants Any infant admitted to the NICU who requires an indwelling urinary catheter as part of their illness will qualify for this study. This group will be further analyzed based on whether their illness is due to abdominal abnormalities or disease or whether there is another serious illness requiring an indwelling urinary catheter. The group will also be analyzed pre and post-operatively.
Intra-abdominal Pressure(IAP) Measurements in NICU Patients.	1219 IAP measurements

SECONDARY outcome

Timeframe: 3 years

Population: 18 of the neonates required staged abdominal surgery for various abdominal abnormalities or disease, while 12 of the neonates were ill due to PPHN, sepsis, or hydrops. All analysis was per protocol.

Intra-abdominal Pressure (IAP) measurements will be tabulated and frequency distributions determined for patients with and without any clinical/surgical abdominal pathology. Median and quartile values will be assessed in order to describe normative values. In patients with clinical abdominal pathology (abdominal distention, necrotizing enterocolitis, abdominal wall defects, diaphragmatic hernia, etc), sequential evaluation of IAP will be done to try to identify thresholds for Intra-abdominal Hypertension (IAH).

Outcome measures

Outcome measures
Measure	Infants With Urinary Catheter in Place n=30 Participants Any infant admitted to the NICU who requires an indwelling urinary catheter as part of their illness will qualify for this study. This group will be further analyzed based on whether their illness is due to abdominal abnormalities or disease or whether there is another serious illness requiring an indwelling urinary catheter. The group will also be analyzed pre and post-operatively.
Median Bladder Pressure for All Measurements	8 mmHg Inter-Quartile Range 7.1 • Interval 3.0 to 10.0

Adverse Events

Infants With Urinary Catheter in Place

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

Donald Null M.D.

University of Utah

Phone: 801.588-3865

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place