Non-nutritive Sucking and Breastfeeding in Preterm Infants

D

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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