Trial Outcomes & Findings for Medical Treatment for Gastroesophageal Reflux Disease (GERD) in Preterm Infants (NCT NCT00131248)
NCT ID: NCT00131248
Last Updated: 2014-01-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
18 participants
Primary outcome timeframe
7 days
Results posted on
2014-01-15
Participant Flow
participants = premature infants, \<36 weeks gestation at birth, recruited from NICU at a hospital in Houston, Texas,USA, between 2004-2009
Participant milestones
| Measure |
Medications, Placebo, Medications (Group 1)
3-day course of anti-reflux medications, followed by 7-day course placebo, followed by 4-day course anti-reflux medications.
All study medication administered via nipple or OG tube. Metaclopramide (anti-reflux) given in 0.1mg/kg/dose q6hrs, 30min. prior to feedings. Ranitidine, 3mg/kg/dose, q12hrs. Saline placebo at same respective volumes.
|
Placebo, Medications, Placebo (Group 2)
received 3-day course placebo, followed by 7-day course anti-reflux medication, followed by 4-day course placebo.
All study medication administered via nipple or OG tube. Metaclopramide (anti-reflux) given in 0.1mg/kg/dose q6hrs, 30min. prior to feedings. Ranitidine, 3mg/kg/dose, q12hrs. Saline placebo at same respective volumes.
|
|---|---|---|
|
Intervention 1 (3-day Course)
STARTED
|
9
|
9
|
|
Intervention 1 (3-day Course)
COMPLETED
|
8
|
9
|
|
Intervention 1 (3-day Course)
NOT COMPLETED
|
1
|
0
|
|
Washout (24 Hour)
STARTED
|
8
|
9
|
|
Washout (24 Hour)
COMPLETED
|
8
|
9
|
|
Washout (24 Hour)
NOT COMPLETED
|
0
|
0
|
|
Intervention 2 (7-day Course)
STARTED
|
8
|
9
|
|
Intervention 2 (7-day Course)
COMPLETED
|
8
|
9
|
|
Intervention 2 (7-day Course)
NOT COMPLETED
|
0
|
0
|
|
Washout 2 (24 Hours)
STARTED
|
8
|
9
|
|
Washout 2 (24 Hours)
COMPLETED
|
8
|
9
|
|
Washout 2 (24 Hours)
NOT COMPLETED
|
0
|
0
|
|
Intervention 3 (4-day Course)
STARTED
|
8
|
9
|
|
Intervention 3 (4-day Course)
COMPLETED
|
8
|
9
|
|
Intervention 3 (4-day Course)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Medications, Placebo, Medications (Group 1)
3-day course of anti-reflux medications, followed by 7-day course placebo, followed by 4-day course anti-reflux medications.
All study medication administered via nipple or OG tube. Metaclopramide (anti-reflux) given in 0.1mg/kg/dose q6hrs, 30min. prior to feedings. Ranitidine, 3mg/kg/dose, q12hrs. Saline placebo at same respective volumes.
|
Placebo, Medications, Placebo (Group 2)
received 3-day course placebo, followed by 7-day course anti-reflux medication, followed by 4-day course placebo.
All study medication administered via nipple or OG tube. Metaclopramide (anti-reflux) given in 0.1mg/kg/dose q6hrs, 30min. prior to feedings. Ranitidine, 3mg/kg/dose, q12hrs. Saline placebo at same respective volumes.
|
|---|---|---|
|
Intervention 1 (3-day Course)
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Medical Treatment for Gastroesophageal Reflux Disease (GERD) in Preterm Infants
Baseline characteristics by cohort
| Measure |
All Study Participants
n=17 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
17 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
|
|
Age, Continuous
|
0.1 years
STANDARD_DEVIATION 0.06 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 daysPopulation: 18 participants originally enrolled, 1 withdrew, leaving 17 participants analyzed.
Outcome measures
| Measure |
Medications
n=17 Participants
|
Placebo
n=17 Participants
|
|---|---|---|
|
Bradycardia Episodes/Day
|
4.6 episodes per day
Standard Deviation 3.1
|
3.6 episodes per day
Standard Deviation 2.7
|
Adverse Events
Medications
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place