Enhanced MotherCARE for procedural pain in preterm neonates

Maternal comfort, analgesia, regulation, endorphin-release: mothercare, a program of research for pain in critically ill infants and toddlers

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13550119

Enrollment

Registered

2006-06-27

Start date

2003-12-01

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 Pregnancy and Childbirth

Interventions

Skin-to-skin contact: the diaper-clad infant will be held upright at an angle of sixty degrees between the breasts of the mother during a routine heel stick procedure. A blanket will be placed over th

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Infants born between 28 0/7 and 32 6/7 weeks post-menstrual age (PMA) as determined by an ultrasound will be eligible.

Exclusion criteria

Exclusion criteria: 1. Genetic or major congenital disorders 2. Requiring surgery before or during the study period 3. Receiving analgesics, paralyzing agents or steroid therapy 4. Apgar scores less than 6 at five minutes 5. Intraventricular haemorrhage (IVH) grade III and/or periventricular leukomalacia (PVL) as confirmed by ultrasound

Design outcomes

Primary

Measure	Time frame
Physiologic stability: 1. Maximum range of heart rate and O2 saturation from baseline throughout the procedure 2. Time to return to baseline heart rate and O2 saturation	—

Secondary

Measure	Time frame
Stress response: measured through the procurement of salivary cortisol collected prior to (basal) and 30 minutes after (stress response) the heel stick procedure for both the mother and the infant.	—

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026