Infant,PrematureNCT03434743
Non-nutritive Sucking and Breastfeeding in Preterm Infants
A study testing Rehabilitative and Active Comparator in people with Infant,Premature and Infant Development, run by Dr. Sandra Fucile at 1 site in Canada.
Trial summary
The main objective of this study is to assess whether non-nutritive sucking on an emptied breast will lead to more success with direct breastfeeding than non-nutritive sucking on a pacifier in preterm infants. Read more about this study
- Who is it for?
- Ages Up to 35 weeks
- Conditions the study is for
- Infant,Premature, Infant Development, Infant, Very Low Birth Weight
- What is being tested?
- Rehabilitative and Active Comparator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteCanada
- Study dates
- 28 Jul 2017to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 35 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- born less than or equal to 34 weeks gestational age (GA);
- appropriate size for their GA;
- receiving nasal continuous positive airway pressure;
- receiving only enteral feedings (orogastric or nasogastric);
- mothers are pumping their milk.
Who cannot join
- congenital anomalies
- mother not expressing milk
- transferred in hospital
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Non-nutritive Sucking on the Breast to Enhance Breastfeeding in Infants Who Are Born Prematurely
The main objective of this study is to assess whether non-nutritive sucking on an emptied breast will lead to more success with direct breastfeeding than non-nutritive sucking on a pacifier in preterm infants.
Read the detailed description
Breast milk is vital in the nourishment of premature infants. Early interventions which focus on enhancing infants' oral motor skills required for breastfeeding are needed. There is very limited evidence on early interventions aimed at maintaining rudimentary sucking skills needed for breastfeeding in this high risk population. The main objective of this study is to assess whether non-nutritive sucking on an emptied breast will enhance breast feeding performance in preterm infants.
The target population will consist of clinically stable preterm infants born less born less than or equal to 34 weeks gestational age and whose mother's intention are to breastfeed. Infants will be randomized into the non-nutritive sucking on emptied breast or pacifier group. Both interventions will be administered by mothers. Time to transition to full oral feeding, breastfeeding acquisition at hospital discharge and breastfeeding duration at six months of age will be monitored.
- Being tested
- Rehabilitative, Active Comparator
- Keywords
- oral feeding, early intervention, premature infant, sucking
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitativeOther
Non-nutritive sucking on emptied breast
Active ComparatorOther
Non-nutritive sucking on pacifier
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitative Intervention | Experimental | Experimental rehabilitative intervention consists of non-nutritive sucking on emptied breast, one time per day for 10 minutes. Receives: Other: Rehabilitative |
| Control Intervention | Active comparator | Control active comparator intervention consists of non-nutritive sucking on a pacifier, one time per day for 10 minutes. Receives: Other: Active Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days to transition from full tube to full oral feeds
Number of days to transition from full tube to full oral (bottle/breast) feedings
Measured: Through study completion, an average of 2 years
Secondary outcomes (2)
Breastfeeding acquisition at hospital discharge
Number of infants receive greater than 50% of direct breastfeeding at hospital discharge
Measured: Through study completion, an average of 2 years
Breastfeeding duration
Number of infants receiving direct breastfeeding 6 months after hospital discharge
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start28 Jul 2017
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant,PrematureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Sandra Fucile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Sandra Fucile, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03434743
- Sponsor's protocol ID
- 6021151
- Status last verified
- Sep 2020
- First submitted
- 29 Jan 2018
- Last updated
- 1 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fucile S, Wener E, Dow K. Enhancing breastfeeding establishment in preterm infants: A randomized clinical trial of two non-nutritive sucking approaches. Early Hum Dev. 2021 May;156:105347. doi: 10.1016/j.earlhumdev.2021.105347. Epub 2021 Mar 10.
PubMed 33714801
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-nutritive Sucking on the Breast to Enhance Breastfeeding in Infants Who Are Born Prematurely
- ClinicalTrials.gov ID
- NCT03434743
- Acronym / sponsor ID
- 6021151
- Keywords
- oral feeding, early intervention, premature infant, sucking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Dr. Sandra FucileUniversity, hospital or other
- Study start
- 28 Jul 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 15 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to assess whether non-nutritive sucking on an emptied breast will lead to more success with direct breastfeeding than non-nutritive sucking on a pacifier in preterm infants.
Detailed description
Breast milk is vital in the nourishment of premature infants. Early interventions which focus on enhancing infants' oral motor skills required for breastfeeding are needed. There is very limited evidence on early interventions aimed at maintaining rudimentary sucking skills needed for breastfeeding in this high risk population. The main objective of this study is to assess whether non-nutritive sucking on an emptied breast will enhance breast feeding performance in preterm infants.
The target population will consist of clinically stable preterm infants born less born less than or equal to 34 weeks gestational age and whose mother's intention are to breastfeed. Infants will be randomized into the non-nutritive sucking on emptied breast or pacifier group. Both interventions will be administered by mothers. Time to transition to full oral feeding, breastfeeding acquisition at hospital discharge and breastfeeding duration at six months of age will be monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitative Intervention | Experimental | Other: RehabilitativeExperimental rehabilitative intervention consists of non-nutritive sucking on emptied breast, one time per day for 10 minutes. |
| Control Intervention | Active comparator | Other: Active ComparatorControl active comparator intervention consists of non-nutritive sucking on a pacifier, one time per day for 10 minutes. |
Who may qualify
- Ages
- Up to 35 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- born less than or equal to 34 weeks gestational age (GA);
- appropriate size for their GA;
- receiving nasal continuous positive airway pressure;
- receiving only enteral feedings (orogastric or nasogastric);
- mothers are pumping their milk.
Key exclusion criteria (3 listed)
- congenital anomalies
- mother not expressing milk
- transferred in hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RehabilitativeNon-nutritive sucking on emptied breast | Other | Rehabilitative Intervention |
| Active ComparatorNon-nutritive sucking on pacifier | Other | Control Intervention |
Primary outcome
Number of days to transition from full tube to full oral feeds
Time frame: Through study completion, an average of 2 years
Number of days to transition from full tube to full oral (bottle/breast) feedings
2 secondary outcomes
Breastfeeding acquisition at hospital discharge
Time frame: Through study completion, an average of 2 years
Breastfeeding duration
Time frame: Through study completion, an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
- Derived from this study: PubMed 33714801Fucile S, Wener E, Dow K. Enhancing breastfeeding establishment in preterm infants: A randomized clinical trial of two non-nutritive sucking approaches. Early Hum Dev. 2021 May;156:105347. doi: 10.1016/j.earlhumdev.2021.105347. Epub 2021 Mar 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitative and Active Comparator in people with Infant,Premature and Infant Development, run by Dr. Sandra Fucile at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days to transition from full tube to full oral feeds (time frame: Through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03434743, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2020.