Non-nutritive Sucking and Breastfeeding in Preterm Infants

Dr. Sandra Fucile

Status: Completed

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

Treatments: Other: Active Comparator; Other: Rehabilitative

Study type: Interventional

Funder types: Other

Identifiers

NCT03434743

6021151

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: Under 35 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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33 participants in 2 patient groups

Rehabilitative Intervention

Experimental group

Description:

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

Treatment:

Other: Rehabilitative

Control Intervention

Active Comparator group

Description:

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

Treatment:

Other: Active Comparator