Pain experienced by infants during vaccination Signs and Symptoms Pain experienced by infants during vaccination
Conditions
Interventions
Interventions as of 30/05/2017:
Participants are randomised to one of two groups using sealed, opaque envelopes stratified by sex.
Intervention group: Infant formula feeding is given at the moment of
Sponsors
University Medical Centre Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: 1. Infants who had been previously been subjected to invasive medical procedures other than the routine medical care neonatal screening heel-lancing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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
| Measure | Time frame |
|---|---|
| 1. Choking in the formula feeding is recorded continually through the study 2. Number of formula feedings their infant had refused after vaccination is recorded by interviewing parents the day after the vaccination 3. Whether the infant had been given acetaminophen (paracetamol) is recorded by interviewing parents the day after the vaccination | — |
Countries
Netherlands
Outcome results
None listed