Non-nutritive Sucking and Breastfeeding in Preterm Infants

• Sponsor: Dr. Sandra Fucile (Other)
• Overall Status: Completed
• CT.gov ID: NCT03434743
• Collaborator: (none)
• Enrollment: 33
• Location: 1
• Arms: 2
• Actual Duration (Months): 23.1
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Infant,Premature; Infant Development; Infant, Very Low Birth Weight	Other: Rehabilitative; Other: Active Comparator	N/A

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

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: The assessor, responsible for data collection and follow up interview post hospitalization, is blind to group assignment.
• Primary Purpose: Treatment
• Official Title: Effect of Non-nutritive Sucking on the Breast to Enhance Breastfeeding in Infants Who Are Born Prematurely
• Actual Study Start Date: Jul 28, 2017
• Actual Primary Completion Date: Jun 30, 2019
• Actual Study Completion Date: Jun 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rehabilitative Intervention Experimental rehabilitative intervention consists of non-nutritive sucking on emptied breast, one time per day for 10 minutes.	Other: Rehabilitative; Non-nutritive sucking on emptied breast
Active Comparator: Control Intervention Control active comparator intervention consists of non-nutritive sucking on a pacifier, one time per day for 10 minutes.	Other: Active Comparator; Non-nutritive sucking on pacifier

Outcome Measures

Primary Outcome Measures

1. Number of days to transition from full tube to full oral feeds [Through study completion, an average of 2 years]

   Number of days to transition from full tube to full oral (bottle/breast) feedings

Secondary Outcome Measures

1. Breastfeeding acquisition at hospital discharge [Through study completion, an average of 2 years]

   Number of infants receive greater than 50% of direct breastfeeding at hospital discharge

2. Breastfeeding duration [Through study completion, an average of 2 years]

   Number of infants receiving direct breastfeeding 6 months after hospital discharge

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 35 Weeks
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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.

Exclusion Criteria:

• congenital anomalies

• mother not expressing milk

• transferred in hospital

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Queen's University	Kingston	Ontario	Canada	K7L2V7

Sponsors and Collaborators

• Dr. Sandra Fucile

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Sandra Fucile, Assistant Professor-adjunct, Queen's University
• ClinicalTrials.gov Identifier: NCT03434743
• Other Study ID Numbers: 6021151
• First Posted: Feb 15, 2018
• Last Update Posted: Oct 1, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dr. Sandra Fucile, Assistant Professor-adjunct, Queen's University: oral feeding; early intervention; premature infant; sucking
• Additional relevant MeSH terms: Birth Weight

Study Results

No Results Posted as of Oct 1, 2020