Skip to content

Kangaroo Care with Father's protocol: an intervention to reduce pain response in preterm neonates (28 - 36 weeks gestation)

Kangaroo Care with Father's protocol: an intervention to reduce pain response in preterm neonates (28 - 36 weeks gestation): a randomised controlled crossover trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN51481987
Enrollment
80
Registered
2009-03-31
Start date
2007-10-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain response during heel lancing Signs and Symptoms Pain response

Interventions

After obtained informed consent from the mother and the father, the neonate will be randomised to intervention (father first mother second) or control (mother first father second). Kangaroo care invol
one with the mother and the other one with the father. The measures will be taken for the entire heel lance procedure (one minute of baseline isolette, one minute of baseline kangaroo, one minute of w

Sponsors

McGill University (Canada)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Born between 28 0/7 and 35 6/7 weeks of gestation, either sex 2. Obtained consent 3. Receiving at least two heel lances prior to discharge 4. Within 10 days of hospitalisation 5. Stable according to Neonatal Intensive Care Unit criteria

Exclusion criteria

Exclusion criteria: 1. Genetic or major congenital disorders 2. Requiring surgery before or during the study period 3. Receiving analgesics or paralysing agents 4. Intra-ventricular haemorrhage (IVH) grade III+ or periventricular leukomalacia (PVL) as confirmed by ultrasound

Design outcomes

Primary

MeasureTime frame
1. Pain measured with Premature Infant Pain Profile (PIPP), repeated over 30 second blocks 2. Facial actions of the PIPP scored according to Neonatal Facial Coding System (NFCS)

Secondary

MeasureTime frame
Timing for return to physiologic baseline measured as the preterm neonate's return to baseline HR after the heel lance procedure procured via an oximeter placed on the unaffected foot of the neonate.

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 28, 2026