Non-nutritive Sucking and Breastfeeding in Preterm Infants

Not Applicable

Completed

• Conditions: Infant,Premature; Infant Development; Infant, Very Low Birth Weight
• Interventions: Other: Rehabilitative; Other: Active Comparator

• Registration Number: NCT03434743
• Lead Sponsor: Dr. Sandra Fucile

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.

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 Timeline

• Study Start: 2017-07-28
• Study First Submitted: 2018-01-29
• Study First Submitted QC: 2018-02-09
• Study First Posted: 2018-02-15
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-29
• Last Update Posted: 2020-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rehabilitative Intervention	Rehabilitative	Experimental rehabilitative intervention consists of non-nutritive sucking on emptied breast, one time per day for 10 minutes.
Control Intervention	Active Comparator	Control active comparator intervention consists of non-nutritive sucking on a pacifier, one time per day for 10 minutes.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Breastfeeding duration	Through study completion, an average of 2 years	Number of infants receiving direct breastfeeding 6 months after hospital discharge
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

Trial Locations

Locations (1)

Queen's University; 🇨🇦 Kingston, Ontario, Canada