Non-nutritive Sucking and Breastfeeding in Preterm Infants

Infant Development Clinical Trial

Official title:

Effect of Non-nutritive Sucking on the Breast to Enhance Breastfeeding in Infants Who Are Born Prematurely

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03434743
• Other study ID #: 6021151
• Status: Completed
• Phase: N/A
• Start date: July 28, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: September 2020
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 35 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Infant Development
• Infant, Very Low Birth Weight
• Infant,Premature

Intervention

Other:
• Rehabilitative
Non-nutritive sucking on emptied breast
• Active Comparator
Non-nutritive sucking on pacifier

Locations

Country	Name	City	State
Canada	Queen's University	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Sandra Fucile

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Breastfeeding duration	Number of infants receiving direct breastfeeding 6 months after hospital discharge	Through study completion, an average of 2 years