Amphia Premature Infant Pain Study

NCT01276366 | Completed

• 1 other identifier: NL30111.101.09
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Heel lance; Premature; Breast milk

Outcome Measures

Primary Outcomes (1)

• 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.

  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 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.

  up to 2 years

• intra-class correlation coefficient

  up to 2 years

Study Arms (3)

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.

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.

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.

Other: breast feeding

Interventions

breast feeding OTHER

Newborns who are assigned to group one, receive breastfeeding during the blood sample and thereby have skin-skin contact between mother and child.

Breast feeding

supplemental breast milk OTHER

In group two, the newborns receive supplemental breast milk, lying in the arms of a nurse during the heel lance.

supplemental breast milk

sucrose OTHER

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.

sucrose

Eligibility Criteria

• Age: 1 Day - 2 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• born at a gestational age between 32+0 and 36+6 weeks,
• being nourished with breast milk
• the necessity for a clinical blood sample.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amphia Hospital: lead

Study Sites (1)

Amphia Hospital

Breda, North Brabant, 4819 VE, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 22392168 DERIVED

MeSH Terms

Conditions

Premature Birth; Breast Feeding

Interventions

Lactation; Sucrose

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Postpartum Period; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• RHT v Beek, phd

  Amphia Hospital Breda

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr. R.H.T. van Beek, Amphia Hospital, pediatric department

Study Record Dates

• First Submitted: April 23, 2010
• First Posted: January 13, 2011
• Study Start: January 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: April 1, 2012
• Last Updated: January 17, 2019

Record last verified: 2019-01

Locations

NL (1)