N/A
N=101
Effects of Prefeeding Oral Stimulation on Feeding Performance in Preterm Infants
Preterm Infant · Oral Feeding Performance
Bottom Line
View on ClinicalTrials.gov: NCT01649362 ↗Enrolled (actual)
101
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcome: Primary: Length of Transition Period — 16.0; 16.9 days — p=0.63
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- prefeeding oral stimulation program (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Centre Hospitalier du Luxembourg
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Length of Transition Period |
16.0; 16.9 | 0.63 |
| SECONDARY Length of Hospital Stay |
42.5; 45.7 | 0.36 |
| SECONDARY Breastfeeding Rate at Discharge |
21; 28 | 0.02 sig |
Summary
The objective of this study is to evaluate the efficacy of an oral stimulation program on the length of the transition period in preterm infants (primary outcome), the length of hospital stay and the breastfeeding rates at discharge (secondary outcomes).
Eligibility Criteria
Inclusion Criteria
- preterm infants from 26 to 33+6 weeks' gestational age, as determined by date of last menstruation and first-trimester ultrasound, hospitalized in our neonatal unit.
Exclusion Criteria
- Congenital malformations (chromosomal disorders, malformations of head and face, neurological, cardiac, digestive or pulmonary malformations)
- Severe asphyxia (hypoxic-ischemic encephalopathy)
- Presence of third or fourth degree intracranial haemorrhage
- Severe periventricular leukomalacia
- Severe chronic lung disease
- Severe hospital infection during the study period
- Necrotising enterocolitis during the study period
- Feeding interruption for more than 10 days during the study period
- Death during the study period
- Transfer to another hospital before discharge.
Data sourced from ClinicalTrials.gov (NCT01649362). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.