Premature InfantAPIPNCT01276366
Amphia Premature Infant Pain Study
A study testing breast feeding, supplemental breast milk and sucrose in people with Premature Infant and Breast Feeding, Exclusive, run by Amphia Hospital at 1 site in Netherlands.
Trial summary
Last thirty years, many research was performed concerning pain in the newborn. These investigations showed us the negative effects of pain in the neonatal period. Our research concerns the choice of analgesics for the premature newborn during a heel lance. Read more about this study
- Who is it for?
- Ages 1 day to 2 monthsHealthy volunteers can take part
- Conditions the study is for
- Premature Infant, Breast Feeding, Exclusive, Puncture Skin
- What is being tested?
- breast feeding, supplemental breast milk and sucrose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2010to 1 Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 2 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- born at a gestational age between 32+0 and 36+6 weeks,
- being nourished with breast milk
- the necessity for a clinical blood sample.
Who cannot join
- perinatal asphyxia,
- birth trauma,
- condition of cardio-respiratory instability,
- condition of serious nutritional problems with clinical evidence of gastro oesophageal reflux disease,
- drug abuse of the mother
- and application of sedative medication to mother or child.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Amphia Premature Infant Pain Study; Breast Milk vs Sucrose
Last thirty years, many research was performed concerning pain in the newborn. These investigations showed us the negative effects of pain in the neonatal period. Our research concerns the choice of analgesics for the premature newborn during a heel lance. Newborns with a gestational age of 32-37 weeks are randomly assigned over three groups. They can receive breastfeeding, during the heel lance, a bottle with supplemental breast milk or sucrose.
The primary objective of the Amphia Premature Infant Pain study, is to investigate whether there is a difference in PIPP-scores in premature newborns who undergo a heel lance, receiving breast milk or sucrose. Our hypothesis is that the PIPP-score will be lower in newborns receiving breast milk compared to sucrose. And the investigators presume that breast feeding has the same analgesic effect as giving supplemental breast milk.
- Conditions
- Premature Infant, Breast Feeding, Exclusive, Puncture Skin
- Being tested
- breast feeding, supplemental breast milk, sucrose
- Keywords
- Heel lance, Premature, Breast milk
- Medical subject headings
- Premature Birth, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breast feedingOther
Newborns who are assigned to group one, receive breastfeeding during the blood sample and thereby have skin-skin contact between mother and child.
supplemental breast milkOther
In group two, the newborns receive supplemental breast milk, lying in the arms of a nurse during the heel lance.
sucroseOther
In the third group, newborns receive sucrose 1ml 24% two minutes before procedure, followed by non-nutritive sucking. During the procedure the newborn lies in his cot.
| Study group | Role | What they receive |
|---|---|---|
| sucrose | Active comparator | In the third group, newborns receive sucrose 1ml 24% two minutes before procedure, followed by non-nutritive sucking. During the procedure the newborn lies in his cot. Receives: Other: sucrose |
| supplemental breast milk | Active comparator | In group two, the newborns receive supplemental breast milk, lying in the arms of a nurse during the heel lance. Receives: Other: supplemental breast milk |
| Breast feeding | Active comparator | Newborns who are assigned to group one, receive breastfeeding during the blood sample and thereby have skin-skin contact between mother and child. Receives: Other: breast feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores assessed by the PIPP score
The primary outcome in this trial is the PIPP-score.The PIPP-score is a multidimensional pain assessment measure developed in 1995 . The PIPP-score is validated for procedural and post-operative pain in premature and term newborns.
Measured: The PIPP score will be assessed during a heellance. This heellance will be performed after one day of life and before two months.
Secondary outcomes (3)
Pain score assessed by the COMFORTneo score
The COMFORTneo is a secondary outcome.The COMFORTneo is a pain assessment measure modified from the COMFORT behaviour scale. In 2009 the COMFORTneo is validated for prolonged pain. The COMFORTneo is not validated for procedural pain yet .
Measured: The COMFORTneo score will be assessed during a heellance. This heellance will be performed after one day of life and before two months.
partial correlation between the two pain assessment tools.
A secondary outcome is the partial correlation between the PIPP-score and the COMFORTneo score for a heellance in babies born with a postconceptional age between 32 and 37 weeks. When all films are observed, the COMFORTneo scores and PIPP scores are evaluated. We measure a partial correlation coefficient between these scores, to compare these two scores.
Measured: up to 2 years
intra-class correlation coefficient
This secondary outcome measure gives us information about the uniformity of the assessment of the films between the three investigators.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study start1 Jan 2010
- Primary completion1 Aug 2011
- Study completion1 Apr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amphia Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, R.H.T. van Beek, Amphia Hospital
- Investigators
- RHT v Beek, phd, Principal investigator, Amphia Hospital Breda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01276366
- Sponsor's protocol ID
- NL30111.101.09
- Acronym
- APIP
- Status last verified
- Jan 2019
- First submitted
- 23 Apr 2010
- Last updated
- 17 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Simonse E, Mulder PG, van Beek RH. Analgesic effect of breast milk versus sucrose for analgesia during heel lance in late preterm infants. Pediatrics. 2012 Apr;129(4):657-63. doi: 10.1542/peds.2011-2173. Epub 2012 Mar 5.
PubMed 22392168
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amphia Premature Infant Pain Study; Breast Milk vs Sucrose
- ClinicalTrials.gov ID
- NCT01276366
- Acronym / sponsor ID
- APIP / NL30111.101.09
- Conditions
- Premature Infant, Breast Feeding, Exclusive, Puncture Skin
- Keywords
- Heel lance, Premature, Breast milk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Amphia HospitalUniversity, hospital or other
- Study start
- 1 Jan 2010
- Primary completion
- 1 Aug 2011 (actual)
- Study completion
- 1 Apr 2012 (actual)
- First posted
- 13 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Last thirty years, many research was performed concerning pain in the newborn. These investigations showed us the negative effects of pain in the neonatal period. Our research concerns the choice of analgesics for the premature newborn during a heel lance. Newborns with a gestational age of 32-37 weeks are randomly assigned over three groups. They can receive breastfeeding, during the heel lance, a bottle with supplemental breast milk or sucrose.
The primary objective of the Amphia Premature Infant Pain study, is to investigate whether there is a difference in PIPP-scores in premature newborns who undergo a heel lance, receiving breast milk or sucrose. Our hypothesis is that the PIPP-score will be lower in newborns receiving breast milk compared to sucrose. And the investigators presume that breast feeding has the same analgesic effect as giving supplemental breast milk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sucrose | Active comparator | Other: sucroseIn the third group, newborns receive sucrose 1ml 24% two minutes before procedure, followed by non-nutritive sucking. During the procedure the newborn lies in his cot. |
| supplemental breast milk | Active comparator | Other: supplemental breast milkIn group two, the newborns receive supplemental breast milk, lying in the arms of a nurse during the heel lance. |
| Breast feeding | Active comparator | Other: breast feedingNewborns who are assigned to group one, receive breastfeeding during the blood sample and thereby have skin-skin contact between mother and child. |
Who may qualify
- Ages
- 1 day to 2 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- born at a gestational age between 32+0 and 36+6 weeks,
- being nourished with breast milk
- the necessity for a clinical blood sample.
Key exclusion criteria (6 listed)
- perinatal asphyxia,
- birth trauma,
- condition of cardio-respiratory instability,
- condition of serious nutritional problems with clinical evidence of gastro oesophageal reflux disease,
- drug abuse of the mother
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| breast feedingNewborns who are assigned to group one, receive breastfeeding during the blood sample and thereby have skin-skin contact between mother and child. | Other | Breast feeding |
| supplemental breast milkIn group two, the newborns receive supplemental breast milk, lying in the arms of a nurse during the heel lance. | Other | supplemental breast milk |
| sucroseIn the third group, newborns receive sucrose 1ml 24% two minutes before procedure, followed by non-nutritive sucking. During the procedure the newborn lies in his cot. | Other | sucrose |
Primary outcome
Pain scores assessed by the PIPP score
Time frame: The PIPP score will be assessed during a heellance. This heellance will be performed after one day of life and before two months.
The primary outcome in this trial is the PIPP-score.The PIPP-score is a multidimensional pain assessment measure developed in 1995 . The PIPP-score is validated for procedural and post-operative pain in premature and term newborns.
3 secondary outcomes
Pain score assessed by the COMFORTneo score
Time frame: The COMFORTneo score will be assessed during a heellance. This heellance will be performed after one day of life and before two months.
partial correlation between the two pain assessment tools.
Time frame: up to 2 years
intra-class correlation coefficient
Time frame: up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2019.
- Derived from this study: PubMed 22392168Simonse E, Mulder PG, van Beek RH. Analgesic effect of breast milk versus sucrose for analgesia during heel lance in late preterm infants. Pediatrics. 2012 Apr;129(4):657-63. doi: 10.1542/peds.2011-2173. Epub 2012 Mar 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
RHT v Beek, phd principal investigator
Amphia Hospital Breda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing breast feeding, supplemental breast milk and sucrose in people with Premature Infant and Breast Feeding, Exclusive, run by Amphia Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores assessed by the PIPP score (time frame: The PIPP score will be assessed during a heellance. This heellance will be performed after one day of life and before two months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01276366, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2019.