The Holding Study: Feeding Analgesia in Preterm Infants

The Holding Pilot Study: Feeding Analgesia in Preterm Infants

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00414258

Enrollment

Registered

2006-12-21

Start date

2006-09-30

Completion date

2007-12-31

Last updated

2011-04-14

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

Conditions

Pain

Keywords

Pain Response

Brief summary

The purpose of this study is to compare the effects of mothers' skin-to-skin holding during feeding via a soother trainer with the effects of pacifier sucking on preterm infant biobehavioural responses during and immediately after a painful procedure Hypothesis: 1. When held by their mothers during blood collection, preterm infants will show less pain reaction than when sucking on a pacifier. 2. Following holding during the blood collection, mothers will find no differences in their infants' feeding ability.

Detailed description

Research Method: In a between subjects, randomized design, 20 stable preterm infants born between 30-35 weeks gestational age will be studied. Infants will be randomized to one of two interventions which will take place during blood collections that are required for clinical management. For the standard care condition, infants will remain in their isolettes and will be positioned in prone and given a pacifier to suck on throughout the blood collection. For the holding condition, infants will be held skin-to-skin by their mothers and given breast milk using a soother trainer during the blood collection.

Interventions

PROCEDUREbreastfeeding

See detailed description.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Days to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Born between 30-35 weeks gestational age * Mother has fluent English

Exclusion criteria

* CNS injury * congenital anomaly * active infection * has had no surgeries or analgesics/sedatives in last 72 hours * history of maternal drug exposure

Design outcomes

Primary

Measure	Time frame
Videotaped and recorded at Baseline, Lance and Recovery:Neonatal Facial Coding System - total facial score; Heart Rate	—

Secondary

Measure	Time frame
Videotaped and Recorded at Baseline, Lance and Recovery:Hand Movements; Sleep/Wake States	—
Samples taken at baseline and recovery;Salivary Cortisol sample	—

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026