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Completed

NCT Number: NCT01276366

Amphia Premature Infant Pain Study

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.

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Key information

Conditions

Premature Infant Behavior Breast Feeding Breast Feeding, Exclusive Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Puncture Skin Urogenital Diseases

Age range

1 day–2 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amphia Hospital

Breda, North Brabant, 4819 VE, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

supplemental breast milk

Other

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

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    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 .

  2. partial correlation between the two pain assessment tools.

    Time frame: up to 2 years

    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.

  3. intra-class correlation coefficient

    Time frame: up to 2 years

    This secondary outcome measure gives us information about the uniformity of the assessment of the films between the three investigators.

Sponsors and collaborators

Lead sponsor

Amphia Hospital

Other

Registry information

Official study title

Amphia Premature Infant Pain Study; Breast Milk vs Sucrose

Acronym: APIP

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jan 13, 2011
Registry last updated
Jan 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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