Trial Outcomes & Findings for Effects of Prefeeding Oral Stimulation on Feeding Performance in Preterm Infants (NCT NCT01649362)

NCT ID: NCT01649362

Last Updated: 2014-03-12

Results Overview

transition period was defined as the period from the introduction of enteral feeding to full enteral feeding

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 101 participants
• Primary outcome timeframe: participants were followed from date of randomization until full enteral feeding was acquired,an expected average of 5 weeks
• Results posted on: 2014-03-12

Participant Flow

Participant milestones

Measure	Control Group no prefeeding oral stimulation	Oral Stimulation preterm infants receiving an prefeeding oral stimulation program
Overall Study STARTED	47	54
Overall Study COMPLETED	46	40
Overall Study NOT COMPLETED	1	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Prefeeding Oral Stimulation on Feeding Performance in Preterm Infants

Baseline characteristics by cohort

Measure	Control Group n=46 Participants no prefeeding oral stimulation	Oral Stimulation n=40 Participants preterm infants receiving an prefeeding oral stimulation program	Total n=86 Participants Total of all reporting groups
Age, Categorical <=18 years	46 Participants n=5 Participants	40 Participants n=7 Participants	86 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
Age, Customized	31.3 weeks' gestational age STANDARD_DEVIATION 1.7 • n=5 Participants	31.4 weeks' gestational age STANDARD_DEVIATION 1.5 • n=7 Participants	31.3 weeks' gestational age STANDARD_DEVIATION 1.6 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	15 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Region of Enrollment Luxembourg	46 participants n=5 Participants	40 participants n=7 Participants	86 participants n=5 Participants

PRIMARY outcome

Timeframe: participants were followed from date of randomization until full enteral feeding was acquired,an expected average of 5 weeks

transition period was defined as the period from the introduction of enteral feeding to full enteral feeding

Outcome measures

Measure	Control Group n=46 Participants no prefeeding oral stimulation	Oral Stimulation n=40 Participants preterm infants receiving an prefeeding oral stimulation program
Length of Transition Period	16.0 days Standard Deviation 6.9	16.9 days Standard Deviation 9.2

SECONDARY outcome

Timeframe: participants were followed for the duration of hospital stay, an expected average of 5 weeks

Outcome measures

Measure	Control Group n=46 Participants no prefeeding oral stimulation	Oral Stimulation n=40 Participants preterm infants receiving an prefeeding oral stimulation program
Length of Hospital Stay	42.5 days Standard Deviation 15.1	45.7 days Standard Deviation 16.8

SECONDARY outcome

Timeframe: hospital discharge, an expected average of 5 weeks from the beginning of oral feeding introduction

Outcome measures

Measure	Control Group n=46 Participants no prefeeding oral stimulation	Oral Stimulation n=40 Participants preterm infants receiving an prefeeding oral stimulation program
Breastfeeding Rate at Discharge	21 participants	28 participants

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Oral Stimulation

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

Dr Manon Bache

Centre Hospitalier de Luxembourg

Phone: +352 4411 3157

Email: manon.bache@hotmail.com

Results disclosure agreements

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