Feeding Maturity in Preterm Infants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-28
SponsorAcibadem University
About this trial
The aim of this study is to evaluate the effect of two pacifier-use strategies-routine 5-minute pacifier use prior to each feeding versus random 30-minute pacifier use at any time of day, independent of feeding-on feeding maturity in preterm infants. The hypotheses of the study are as follows: H1: The routine use of a pacifier prior to feeding has a positive effect on feeding maturity in preterm infants.
H2: The routine use of a pacifier prior to feeding has a positive effect on discharge weight in preterm infants.
H3: The routine use of a pacifier prior to feeding has a positive effect on the length of hospital stay in preterm infants.
H4: The routine use of a pacifier prior to feeding has a positive effect on the gestational age at discharge in preterm infants.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Preterm
who are clinically stable, and
who are within the first day of initiating enteral feeding.
Disqualifiers
Newborns who have a contraindication to pacifier use
have comorbid medical conditions
who are intubated
have congenital anomalies
Trial design
Design model
Parallel
Treatments tested in this trial
Routine NNS
DeviceThe content, volume, and method of feeding are determined by the physician. A pacifier is provided for 5 minutes before each feeding. Procedures are carried out in accordance with the "Newborn Nursing Protocols," based on the infant's feeding method. Feeding maturity is assessed once a week using a feeding monitor.
Random NNS
DeviceThe content, volume, and method of feeding are determined by the physician. The infant is given a pacifier for 30 minutes at random times during the day, independent of feeding. Procedures are carried out in accordance with the "Newborn Nursing Protocols," based on the infant's feeding method. Feeding maturity is assessed once a week using a feeding monitor.
Treatment groups
62 Participants
are divided into 2 treatment groupsGroup A: Routine NNSExperimental treatment 1 intervention
Group B: Control group (Random NNS)Other 1 intervention
Trial outcomes
Primary outcomes
1
Feeding maturity
Feeding maturity will be evaluated using a feeding monitor, assessing key swallowing and respiratory coordination parameters, including the number and duration of rhythmic swallows, rest periods, swallow-respiration patterns, and total milk volume consumed.
Time frame
From the start of oral feeding until hospital discharge; assessed weekly for up to 6 weeks. The change in these time intervals will be assessed.Secondary outcomes
1
Change in Body Weight
Participant's body weight will be assessed at initiation of total oral feeding and at hospital discharge.
Time frame
From initiation of total oral feeding to hospital discharge (average 5 weeks)2
Length of Hospital Stay
The time from date of hospitalization until the date of discharge.
Time frame
From baseline to discharge (average 15 weeks)3
Age at discharge
Postmenstrual age (weeks) of the infant at the time of hospital discharge.
Time frame
At first discharge home, on average 37 weeks postmenstrual ageSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov