Condition category
Signs and Symptoms
Date applied
12/11/2015
Date assigned
06/12/2015
Last edited
12/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Vaccinations are one of the best ways to protect babies from serious childhood diseases. The 5-in-1 vaccine (also known as the DTaP/IPV/Hib vaccine) and the pneumococcal vaccine are among the most important vaccinations a child will have in their first few months of life, protecting against illnesses which are potentially disabling or even fatal. In many cases, children can find the vaccination experience painful and unpleasant, which can be extremely distressing to their parents. Previous studies have found that breastfeeding a baby or feeding them sugar water before, during and after their vaccination can help to soothe them, and appear to reduce pain. Currently, there is no real evidence whether this works with baby formula. Many parents choose to feed their baby using formula, and so these children are not able to receive the soothing effects of breastfeeding in their vaccinations. The aim of this study is to find out whether feeding babies formula during their routine vaccinations can help to lower pain levels and stop them from crying.

Who can participate?
Healthy, formula fed babies who are between 4-9 weeks old at the time of their vaccinations.

What does the study involve?
Participants are placed into one of two groups. Those in the first group are given formula milk to drink from 2 minutes before their vaccination until afterwards, for as long as they like. Those in the second group are not given anything to put in their mouths. Children in both groups are held and comforted by their parents during their vaccinations. Throughout the study, the children in both groups are watched to see if they are showing any signs of being in pain, and if they cry, for how long. The day after the vaccinations, the parents of the children who were given formula are contacted in order to find out if they have refused their formula or if their children needed pain relief (paracetamol) at any point.

What are the possible benefits and risks of participating?
Participants in the feeding group may experience less pain during their vaccination. There is a small risk that children in the feeding group may choke on the formula during the vaccination or refuse the formula after the vaccination.

Where is the study run from?
University Medical Centre Groningen (Netherlands)

When is the study starting and how long is it expected to run for?
September 2014 to December 2014

Who is funding the study?
The Public Child Healthcare organization of Groningen (Netherlands)

Who is the main contact?
Mrs Netty Bos-Veneman

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Netty Bos-Veneman

ORCID ID

http://orcid.org/0000-0002-3059-9339

Contact details

Industrieweg 10
Loppersum
9919je
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Formula feeding as pain reducing method during vaccination

Acronym

Study hypothesis

Formula feeding during vaccination reduces pain experienced by infants.

Ethics approval

The Medical Ethical Committee of the University Hospital of Groningen (Netherlands) has exempted this study from medical ethical evaluation (METc UMCG 2014.274) because the intervention used (formula feeding) is familiar to the child, not invasive, most probably without clinically relevant side effects. Thereby pain was only measured once by observation.

Study design

Single-centre case-control study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a client information sheet.

Condition

Pain experienced by infants during vaccination

Intervention

All infants receive pain reduction through sitting in half supine position on the lap of their parent, who comforted their infant in their own way, for example by talking and cradling. Infants in the study group drink formula milk for two minutes before they receive vaccination, and they continue to drink during and after the vaccination as long as they like. Infants in the comparator group do not have anything in their mouths during this time. Infants in both groups are observed throughout the vaccinations and afterwards so that their level of pain can be predicted i.e. from crying, movement, facial expression etc.

Intervention type

Other

Phase

Drug names

Primary outcome measures

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 outcome measures

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

Overall trial start date

01/09/2014

Overall trial end date

15/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged between 4-9 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

Participant type

Healthy volunteer

Age group

Neonate

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Infants who had been previously been subjected to invasive medical procedures other than the routine medical care neonatal screening heel-lancing

Recruitment start date

01/10/2014

Recruitment end date

15/12/2014

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Centre Groningen
Hanzeplein 120
Groningen
9919je
Netherlands

Sponsor information

Organisation

University Medical Centre Groningen

Sponsor details

Hanzeplein 1
Groningen
9700RB
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

Hospital/treatment centre

Funder name

The Public Child Healthcare organization of Groningen (GGD)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish the results regarding the pain scores, cry duration and possible adverse effects in a peer reviewed paper.

Intention to publish date

31/12/2015

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes