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Trial Outcomes & Findings for Characteristics of Cord Blood Immunologic Parameters of Infants <32 Weeks Gestation (NCT NCT00524394)

NCT ID: NCT00524394

Last Updated: 2015-12-14

Results Overview

Describe changes in immunological homeostasis that indicate the "normal" function vs. presence of sepsis in newborn infants of various gestational ages

Recruitment status

TERMINATED

Target enrollment

2 participants

Primary outcome timeframe

0 to 30 days of life.

Results posted on

2015-12-14

Participant Flow

Recruitment using NICU ADMISSION LIST.

Participant milestones

Participant milestones
Measure
Infants 0 to 3 Days of Life >1500 g or >32 Weeks GA
Infants born at \>32 weeks of gestagional age or \> 1500gm between 0 to 3 Days of Life
Overall Study
STARTED
2
Overall Study
COMPLETED
1
Overall Study
NOT COMPLETED
1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Characteristics of Cord Blood Immunologic Parameters of Infants <32 Weeks Gestation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
INFANTS
n=2 Participants
INFANTS 0 to 3 days of life \>1500 G OR \>32 WEEKS GA
Age, Categorical
<=18 years
2 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
0 Participants
n=5 Participants
Sex: Female, Male
Male
2 Participants
n=5 Participants
Region of Enrollment
United States
2 participants
n=5 Participants

PRIMARY outcome

Timeframe: 0 to 30 days of life.

Describe changes in immunological homeostasis that indicate the "normal" function vs. presence of sepsis in newborn infants of various gestational ages

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: O TO 30 DAYS OF LIFE

Population: zero participant analyzed

IL2 IL6 IL8 IL13 MIP1B MCP1 IL1B IL4 IL5 IL7 IL10 IL12P70 Measure of Cytokines presence and level .

Outcome measures

Outcome data not reported

Adverse Events

Infants0-3 Days of Life >1500g or >32 Weeks GA

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

James Murphy, PhD

University of Texas Health Science Center

Phone: 713-500-5714

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place