Non-nutritive Sucking and Breastfeeding in Preterm Infants

NCT ID: NCT03434743

Last Updated: 2020-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-28
• Study Completion Date: 2019-06-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Rehabilitative Intervention

Experimental rehabilitative intervention consists of non-nutritive sucking on emptied breast, one time per day for 10 minutes.

Group Type: EXPERIMENTAL

Rehabilitative

Intervention Type: OTHER

Non-nutritive sucking on emptied breast

Control Intervention

Control active comparator intervention consists of non-nutritive sucking on a pacifier, one time per day for 10 minutes.

Group Type: ACTIVE_COMPARATOR

Active Comparator

Intervention Type: OTHER

Non-nutritive sucking on pacifier

Interventions

Rehabilitative

Non-nutritive sucking on emptied breast

Intervention Type: OTHER

Active Comparator

Non-nutritive sucking on pacifier

Intervention Type: OTHER

Eligibility Criteria

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

• Maximum Eligible Age: 35 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Sandra Fucile

OTHER

Sponsor Role: lead

Responsible Party

Dr. Sandra Fucile

Assistant Professor-adjunct

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Queen's University

Kingston, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 33714801 (View on PubMed)

Other Identifiers

6021151

Identifier Type: -

Identifier Source: org_study_id