Does drinking formula milk reduce the pain that infants experience during vaccination?
Completed
- Conditions
- Pain experienced by infants during vaccinationSigns and Symptoms
- Registration Number
- ISRCTN32182704
- Lead Sponsor
- niversity Medical Centre Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 56
Inclusion Criteria
1. Aged between 4-10 weeks old when they received their first DTaP-IPV-HepB-Hib and pneumococcal vaccination as part of the Dutch National Immunization Program
2. Healthy infants
3. Full term born
Exclusion Criteria
1. Infants who had been previously been subjected to invasive medical procedures other than the routine medical care neonatal screening heel-lancing
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Pain is measured using the Neonatal Infant Pain Scale (NIPS) and Face, Legs, Activity, Cry, and Consolability (FLACC) during two periods of fifteen seconds beginning at the moment of injection and 60 seconds after injection<br>2. Cry duration is assessed by measuring the duration of high-frequency and rhythmic vocal expression of the infant between the moment of injection until a period of silence of at least five seconds.
- Secondary Outcome Measures
Name Time Method 1. Choking in the formula feeding is recorded continually through the study<br>2. Number of formula feedings their infant had refused after vaccination is recorded by interviewing parents the day after the vaccination<br>3. Whether the infant had been given acetaminophen (paracetamol) is recorded by interviewing parents the day after the vaccination