ClinicalTrials.gg
CompletedNCT03421158Updated Feb 5, 2018

Non-pharmacological Analgesic Effects on Term Newborns

An interventional study of breastfeeding and oral sucrose in Pain and Breast Feeding, sponsored by Stanford University. Completed. Open to participants aged 24 Hours to 48 Hours, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-05.

Sponsored by Stanford University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 2 months after the study started (first participant enrolled Nov 2014, registered Jan 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
236
Allocation
Randomized
Ages
24 Hours to 48 Hours
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 17 studies testing sucrose in Pain — none open to participants now, none under way, none of them phase 3. Sucrose · Pain.

Enrollment
6th of 17
236 · median 120
Started
2014
the only one that year
No phase
6 of 17
none open now
Registered
16th of 17
by date
Lead sponsor
1 of 17
Stanford University

Among the 17 studies testing sucrose in Pain, this one is the 6th largest by enrollment, is the only one that started in 2014, is one of 6 with no phase, and was the 16th registered.

Pain

10,060 studies on the registry are indexed under Pain; 1,651 are open to participants now.

Browse Pain studies →

Open to participants now

None of the 17 studies testing sucrose in Pain is open now. The open studies under Pain, anywhere →

About sucrose

No approval found in the FDA or EMA files read. How studies give it is on its page →

Who these studies take

Of the 929 Pain studies recruiting now, 384 (41%) set no upper age limit and 434 (47%) stop at 75 or younger; 146 take children under 18; 222 take healthy volunteers.

This study: 24 Hours to 48 Hours · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Download CSVNarrow it in search →With an account: the 17 studies testing sucrose in Pain as a file.
02

Study summary

The purpose of this study is to compare the analgesic effects of four non-pharmacological interventions: skin-to-skin contact, breastfeeding, oral sucrose and nonnutritive sucking in newborns receiving a heel lance procedure.

Read the detailed description

This is an randomized control clinical study. study population is healthy term newborns.Patients were identified by chart review and consent was received by nurse researcher. Newborns were randomized into either the control group who received no pain intervention or the intervention group who received one of four non-pharmacological pain interventions: skin to skin contact, breastfeeding, oral sucrose, and nonnutritive sucking.

A heel lance for newborn screen blood sampling was selected as a study procedure and performed by a hospital technician following standard protocol. Pain scoring was assessed by two research nurses after the hell lance and through the procedure. Neonatal Pain, Agitation and Sedation Scale (NPASS) was selected as a pain assessment tool for this study.

The average pain score from two research nurses were used for statistical analysis.

03

Conditions studied

  • Pain
  • Breast Feeding

Keywords

  • neonates
  • Non-pharmacological
04

Who can participate

Ages eligible
24 Hours to 48 Hours
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Gestational Age 38-40
  • 2.5-4.0kg
  • 24-48hours of age
  • Receiving heel lance procedure
  • Apgar>7 at birth
  • NPASS\<3 at time of heel lance

Exclusion criteria

Exclusion Criteria:

  • Prior heel lance procedure
  • birth trauma
  • forceps or vacuum delivery
  • maternal drug abuse during delivery
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
236 participants (actual)

Study arms

  • No intervention
    Control

    Newborns received no pain interventions during the procedure

  • Experimental
    Breastfeeding

    Newborns were breastfed during the procedure

    Behavioral: breastfeeding

  • Experimental
    Oral Sucrose

    Newborns were given oral sucrose during the procedure

    Dietary Supplement: oral sucrose

  • Experimental
    Skin to skin contact

    Newborns were placed in direct contact with their mothers during the procedure

    Behavioral: Skin-to-Skin contact

  • Experimental
    Non-nutritive sucking

    Newborns were given a pacifier to suck on during the procedure

    Behavioral: Non-nutritive sucking

Interventions

  • Behavioralbreastfeeding

    Newborns were breastfed during the procedure

  • Dietary supplementoral sucrose

    Newborns were given oral sucrose during the procedure

  • BehavioralSkin-to-Skin contact

    Newborns were placed in direct contact with their mothers during the procedure

  • BehavioralNon-nutritive sucking

    newborns were given a pacifier to suck on during the procedure

    Also known as: Pacifier

06

What researchers measure

Primary outcomes

  1. Decrease in Neonatal Pain, Agitation and Sedation Scale (NPASS) scores for newborns receiving non-pharmacologic interventions

    Neonatal Pain, Agitation and Sedation Scale (NPASS) measures both behavioral and physiological components of pain by evaluating five key elements, and scores pain from 0-10 (Patricia A. Hummel, 2004). The assessment criteria are crying irritability, behavior state, facial expression, extremities tone, and vital signs.

    Time frame: 12 month

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2014 to primary completion in Sep 2015, 10 months.

Of 3,734 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's 10 months is close to that.

Counting every sponsor, half of 3,833 studies reached it within 10 months; a quarter within 4 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 29, 2018
First posted
Feb 5, 2018
StartActual
Nov 7, 2014
Primary completionActual
Sep 30, 2015
CompletionActual
Aug 31, 2017
Last update
Feb 5, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03421158
Responsible party
Annette Nasr (Clinical Assistant Professor, Pediatrics, Stanford University) — Principal investigator
First posted
Feb 5, 2018
Start date
Nov 7, 2014
Primary completion
Sep 30, 2015
Completion
Aug 31, 2017
Last update
Feb 5, 2018

Study contacts

Jie Chang, BSN,MD
principal investigator · Stanford University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Sucrose

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