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Completed

NCT Number: NCT03434743

Non-nutritive Sucking and Breastfeeding in Preterm Infants

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.

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Key information

Age range

Up to 35 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen's University

Kingston, Ontario, K7L2V7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rehabilitative

Other

Non-nutritive sucking on emptied breast

Active comparator

Other

Non-nutritive sucking on pacifier

Primary outcomes

  1. Number of days to transition from full tube to full oral feeds

    Time frame: Through study completion, an average of 2 years

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

Secondary outcomes

  1. Breastfeeding acquisition at hospital discharge

    Time frame: Through study completion, an average of 2 years

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

  2. Breastfeeding duration

    Time frame: Through study completion, an average of 2 years

    Number of infants receiving direct breastfeeding 6 months after hospital discharge

Sponsors and collaborators

Lead sponsor

Dr. Sandra Fucile

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 15, 2018
Registry last updated
Oct 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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