N/A
N=130
Maternal Role in Oral Feed Establishment in Preterm Neonates
Preterm Birth · Tube Feeding · Swallowing Disorder · Maternal Care Patterns
Bottom Line
View on ClinicalTrials.gov: NCT05484726 ↗Enrolled (actual)
130
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Transition Time to Full Oral Feeding — 10; 9 days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- perioral sensory motor stimulation (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Fatima Memorial Hospital
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Transition Time to Full Oral Feeding |
10; 9 | — |
| PRIMARY Improvement (Change) in Efficiency in Oral Feed Establishment |
0; 0; 9; 12; 15; 16 | — |
| PRIMARY •Adverse Outcome Monitoring |
31; 36; 14; 14; 12; 12 | — |
| PRIMARY •Adverse Events Monitoring |
31; 36; 14; 14; 12; 12 | — |
| SECONDARY • Total Volume Taken During Each Feeding |
2; 2; 3; 5; 4; 7 | — |
| SECONDARY • Volume Taken During the First 5 Min of Feeding (ml) VT5 |
2; 2; 3; 3; 3; 3 | — |
| SECONDARY •Rate of Transfer (RT) ml/Min |
0.42; 0.42; 0.71; 0.70; 0.70; 0.70 | — |
| SECONDARY • Overall Transfer (OT Percent) Volume Taken/Total Volume Prescribed |
21; 21; 35.7; 36; 43.8; 43.8 | — |
| SECONDARY • Proficiency(PRO Percent) Volume Taken During the First 5 Min/Total Volume Prescribed |
16; 16; 21; 21.6; 19.5; 23 | — |
| SECONDARY • Neonates Feeding With SSB Coordination |
23; 22; 27; 33; 32; 33 | — |
Summary
Hypothesis
Preterm babies who receive sensory motor stimulation from their mothers as compared to trained nurses will
1. Start taking oral feed at the same time as compared to control group
2. Take the same amount of milk at the commencement of oral feeding
3. Take milk with equal efficiency
4. Not face more adverse effects
Eligibility Criteria
Inclusion Criteria
- All preterm of gestation age 28 to 34weeks
- Haemodynamically stable
- Established full Gavage feed
- No respiratory distress
- No need for respiratory support except LFNC
- Do not receive any kind of analgesics
Exclusion Criteria
- Syndromic babies /genetic disorders
- Haemodynamically unstable babies including IVH (grade III & IV), hemodynamically significant PDA on treatment, NEC(stage III)
- Major malformations
- Cleft lip and palate
- Anemia requiring blood transfusion
Data sourced from ClinicalTrials.gov (NCT05484726). 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.