Trial Outcomes & Findings for Impact of Oral Application of Gastrografin on the Meconium Evacuation in Very Low Birth Weight Infants (NCT NCT01515696)

NCT ID: NCT01515696

Last Updated: 2014-07-18

Results Overview

Time to complete meconium evacuation in days of life until the complete meconium evacuation from birth up to 40 days of life

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 96 participants
• Primary outcome timeframe: days of life until until the complete meconium evacuation from birth up to 40 days of life
• Results posted on: 2014-07-18

Participant Flow

3 year study period 789 infants were eligible for enrollment in the study

Six hundred ninety-three infants were excluded for the following reasons: informed consent was not obtained in time(n = 660), parental refusal (n = 21), and 12 infants died before randomization.

Participant milestones

Measure	Gastrografin infants received 3ml/kg Gastrografin + 6ml/kg sterile water once during the first 24 hours of life via gastric tube	Sterile Water infants received 9ml/kg sterile water once during the first 24 hours of life via gastric tube
Overall Study STARTED	47	49
Overall Study COMPLETED	39	39
Overall Study NOT COMPLETED	8	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impact of Oral Application of Gastrografin on the Meconium Evacuation in Very Low Birth Weight Infants

Baseline characteristics by cohort

Measure	Gastrografin n=47 Participants infants receive 3ml/kg Gastrografin + 6ml/kg sterile water	Sterile Water n=49 Participants infants receive 9ml/kg sterile water	Total n=96 Participants Total of all reporting groups
Age, Categorical <=18 years	47 Participants n=5 Participants	49 Participants n=7 Participants	96 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	20 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	29 Participants n=7 Participants	49 Participants n=5 Participants
Region of Enrollment Austria	47 participants n=5 Participants	49 participants n=7 Participants	96 participants n=5 Participants
birthweight	870 grams FULL_RANGE 0 • n=5 Participants	900 grams FULL_RANGE 0 • n=7 Participants	879 grams FULL_RANGE 0 • n=5 Participants

PRIMARY outcome

Timeframe: days of life until until the complete meconium evacuation from birth up to 40 days of life

Population: per protocol

Time to complete meconium evacuation in days of life until the complete meconium evacuation from birth up to 40 days of life

Outcome measures

Measure	Gastrografin n=39 Participants infants receive 3ml/kg Gastrografin + 6ml/kg sterile water	Sterile Water n=39 Participants infants receive 9ml/kg sterile water
Time to Complete Meconium Evacuation in Days	7 days of life Interval 3.0 to 16.0	8 days of life Interval 1.0 to 24.0

SECONDARY outcome

Timeframe: days of life from birth until an infant tolerates en enteral feeding volume of 140 ml/kg

Population: per protocol

full enteral feeding is defined in days of life from birth until an an infant tolerates an enteral feeding volume of 140ml/kg

Outcome measures

Measure	Gastrografin n=39 Participants infants receive 3ml/kg Gastrografin + 6ml/kg sterile water	Sterile Water n=39 Participants infants receive 9ml/kg sterile water
Feeding Tolerance- Full Enteral Feedings	19 days Interval 10.0 to 68.0	26.5 days Interval 9.0 to 109.0

POST_HOC outcome

Timeframe: End of study

necrotizing enterocolitis stage 2a after Bell

Outcome measures

Measure	Gastrografin n=39 Participants infants receive 3ml/kg Gastrografin + 6ml/kg sterile water	Sterile Water n=39 Participants infants receive 9ml/kg sterile water
Necrotizing Enterocolitis	8 participants	3 participants

Adverse Events

Gastrografin

Serious events: 43 serious events

Other events: 5 other events

Deaths: 0 deaths

Sterile Water

Serious events: 42 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Gastrografin n=47 participants at risk infants receive 3ml/kg Gastrografin + 6ml/kg sterile water	Sterile Water n=49 participants at risk infants receive 9ml/kg sterile water
Nervous system disorders intraventricular haemorrhage	6.4% 3/47 • Number of events 3 • from birth until discharge of the infant with a maximum of 5 months	6.1% 3/49 • Number of events 3 • from birth until discharge of the infant with a maximum of 5 months
Gastrointestinal disorders necrotizing enterocolitis	21.3% 10/47 • Number of events 10 • from birth until discharge of the infant with a maximum of 5 months	8.2% 4/49 • Number of events 4 • from birth until discharge of the infant with a maximum of 5 months
Cardiac disorders persistent ductus arteriosus	46.8% 22/47 • Number of events 22 • from birth until discharge of the infant with a maximum of 5 months	57.1% 28/49 • Number of events 28 • from birth until discharge of the infant with a maximum of 5 months
Congenital, familial and genetic disorders death	17.0% 8/47 • Number of events 8 • from birth until discharge of the infant with a maximum of 5 months	14.3% 7/49 • Number of events 7 • from birth until discharge of the infant with a maximum of 5 months

Other adverse events

Measure	Gastrografin n=47 participants at risk infants receive 3ml/kg Gastrografin + 6ml/kg sterile water	Sterile Water n=49 participants at risk infants receive 9ml/kg sterile water
Infections and infestations culture proven sepsis	10.6% 5/47 • Number of events 5 • from birth until discharge of the infant with a maximum of 5 months	12.2% 6/49 • Number of events 6 • from birth until discharge of the infant with a maximum of 5 months

Additional Information

Nadja Haiden M.D.

Medical University of Vienna

Phone: +431404003232

Email: nadja.haiden@meduniwien.ac.at

Results disclosure agreements

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