Trial Outcomes & Findings for Collaborative Research Group for Necrotizing Enterocolitis (NCT NCT00828451)

Results Overview

Salivary EGF protein levels obtained from oral swabs were analyzed by commercially available EGF ELISA kit (R \&D systems Inc). EGF protein levels were normalized to micrograms of protein in saliva, and expressed as picogram of EGF protein per microgram of total salivary protein.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

29 participants

Primary outcome timeframe

Sampling occurred on average day of life 9 with a range from day of life 7 to 21

Results posted on

2018-04-04

Participant Flow

Subjects admitted to the neonatal intensive care unit at St. Louis Children's Hospital were screened and enrolled from 5/1/2008 to 12/31/2009. Infants born at \< 32 weeks and 7 days old or less were eligible for enrollment which occurred in the neonatal intensive care unit or postpartum floor.

After enrollment 11 of 29 enrolled subjects did not complete the study due to removal of the intravenous line required for infusion, significant deterioration in clinical status resulting in unstable condition as identified by the attending physician, parental withdrawal, and death.

Participant milestones

Participant milestones
Measure	Preterm Infants for EGF Profiles Premature infants born at \< 32 weeks gestation who are 7 days old or less. Infants received and intravenous infusion of \[5,5,5-2H3\]leucine (stable isotope labeled leucine) with sampling of blood, urine and saliva.
Overall Study STARTED	29
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Preterm Infants for EGF Profiles Premature infants born at \< 32 weeks gestation who are 7 days old or less. Infants received and intravenous infusion of \[5,5,5-2H3\]leucine (stable isotope labeled leucine) with sampling of blood, urine and saliva.
Overall Study Death	2
Overall Study Lack of intravenous line	7
Overall Study Withdrawal by Subject	1
Overall Study Deterioration in clinical status	1

Baseline Characteristics

Collaborative Research Group for Necrotizing Enterocolitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Preterm Infants for EGF Profiles n=18 Participants Premature infants born at \< 32 weeks gestation who are 7 days old or less. Infants received and intravenous infusion of \[5,5,5-2H3\]leucine (stable isotope labeled leucine) with sampling of blood, urine and saliva.
Age, Categorical <=18 years	18 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	4 Days n=93 Participants
Sex: Female, Male Female	6 Participants n=93 Participants
Sex: Female, Male Male	12 Participants n=93 Participants
Region of Enrollment United States	18 Participants n=93 Participants

PRIMARY outcome

Timeframe: Sampling occurred on average day of life 9 with a range from day of life 7 to 21

Population: 29 subjects were enrolled with 11 not completing the study and not analyzed due to lack of specimens

Salivary EGF protein levels obtained from oral swabs were analyzed by commercially available EGF ELISA kit (R \&D systems Inc). EGF protein levels were normalized to micrograms of protein in saliva, and expressed as picogram of EGF protein per microgram of total salivary protein.

Outcome measures

Outcome measures
Measure	Preterm Infants for EGF Profiles n=18 Participants Premature infants born at \< 32 weeks gestation who are 7 days old or less. Infants received and intravenous infusion of \[5,5,5-2H3\]leucine (stable isotope labeled leucine) with sampling of blood, urine and saliva.
Salivary EGF (Epidermal Growth Factor) Protein Levels	15 picograms EGF/ microgram of protein Interval 6.0 to 61.0

PRIMARY outcome

Timeframe: Sampling occurred on average day of life 9 with a range from day of life 7 to 21

Population: 29 subjects were enrolled; 11 did not complete the study and were not analyzed

Urinary EGF protein levels obtained from free flowing urine samples retrieved from subject diaper were analyzed by commercially available EGF ELISA kit (R \&D systems Inc). EGF protein levels were normalized to milligrams of creatinine in urine, and expressed as nanograms of EGF protein per milligram of urinary creatinine.

Outcome measures

Outcome measures
Measure	Preterm Infants for EGF Profiles n=18 Participants Premature infants born at \< 32 weeks gestation who are 7 days old or less. Infants received and intravenous infusion of \[5,5,5-2H3\]leucine (stable isotope labeled leucine) with sampling of blood, urine and saliva.
Urinary EGF Protein Levels	48 nanograms of EGF/mg of creatinine Interval 7.0 to 146.0

SECONDARY outcome

Timeframe: Sampling occurred on average day of life 9 with a range from day of life 7 to 21

Population: 29 subjects were enrolled; 11 did not complete the study and were not analyzed

Identification of computationally predicted functional variants in EGF gene

Outcome measures

Outcome measures
Measure	Preterm Infants for EGF Profiles n=18 Participants Premature infants born at \< 32 weeks gestation who are 7 days old or less. Infants received and intravenous infusion of \[5,5,5-2H3\]leucine (stable isotope labeled leucine) with sampling of blood, urine and saliva.
EGF Gene Sequencing	11 percentage of participants with variant

Adverse Events

Preterm Infants for EGF Profile

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Aaron Hamvas, MD

Washington University

Phone: 314-454-6148

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place