Non-nutritive Sucking and Breastfeeding in Preterm Infants

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.

Study Overview

• Status: Completed
• Conditions: Infant Development; Infant, Very Low Birth Weight; Infant,Premature
• Intervention / Treatment: Other: Rehabilitative; Other: Active Comparator

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 Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L2V7
      • Queen's University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 8 months (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breastfeeding acquisition at hospital discharge	Number of infants receive greater than 50% of direct breastfeeding at hospital discharge	Through study completion, an average of 2 years
Breastfeeding duration	Number of infants receiving direct breastfeeding 6 months after hospital discharge	Through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Dr. Sandra Fucile

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 28, 2017
• Primary Completion (ACTUAL): June 30, 2019
• Study Completion (ACTUAL): June 30, 2019

Study Registration Dates

• First Submitted: January 29, 2018
• First Submitted That Met QC Criteria: February 9, 2018
• First Posted (ACTUAL): February 15, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 1, 2020
• Last Update Submitted That Met QC Criteria: September 29, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: oral feeding; early intervention; premature infant; sucking
• Additional Relevant MeSH Terms: Body Weight; Birth Weight
• Other Study ID Numbers: 6021151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No