Feeding Maturity in Preterm Infants

NCT07273266 | Recruiting

• 1 other identifier: ATADEK-2024/19
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preterm; Feeding; Non Nutritive Sucking

Keywords

preterm; feeding; non nutritive sucking; feeding maturation

Outcome Measures

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.

  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 (3)

• Change in Body Weight

  From initiation of total oral feeding to hospital discharge (average 5 weeks)

• Length of Hospital Stay

  From baseline to discharge (average 15 weeks)

• Age at discharge

  At first discharge home, on average 37 weeks postmenstrual age

Study Arms (2)

Routine NNS

EXPERIMENTAL

Newborns who receive routine 5-minute pacifier use before each feeding will constitute the intervention group.

Device: Routine NNS

Control group (Random NNS)

OTHER

Newborns who are given a pacifier for 30 minutes at random times throughout the day, independent of feeding and based on the infant's cues, will constitute the control group.

Device: Random NNS

Interventions

Routine NNS DEVICE

The 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.

Routine NNS

Random NNS DEVICE

The 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.

Control group (Random NNS)

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Preterm
• who are clinically stable, and
• who are within the first day of initiating enteral feeding.

You may not qualify if:

• Newborns who have a contraindication to pacifier use
• have comorbid medical conditions
• who are intubated
• have congenital anomalies

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acıbadem University

Istanbul, Ataşehir, 34750, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• Foster JP, Psaila K, Patterson T. Non-nutritive sucking for increasing physiologic stability and nutrition in preterm infants. Cochrane Database Syst Rev. 2016 Oct 4;10(10):CD001071. doi: 10.1002/14651858.CD001071.pub3.

  PMID: 27699765 BACKGROUND

• Kaya V, Aytekin A. Effects of pacifier use on transition to full breastfeeding and sucking skills in preterm infants: a randomised controlled trial. J Clin Nurs. 2017 Jul;26(13-14):2055-2063. doi: 10.1111/jocn.13617. Epub 2017 Mar 21.

  PMID: 27754572 BACKGROUND

• Ecevit A, Erdogan B, Anuk Ince D, Aksu M, Unal S, Turan O, Saracoglu A, Tarcan A. Determination of oral feeding skills in late preterm, early term, and full-term infants using the neonatal oral feeding monitor (NeoSAFE). Ital J Pediatr. 2025 Feb 7;51(1):38. doi: 10.1186/s13052-025-01867-2.

  PMID: 39920842 BACKGROUND

• Munoz-Gomez E, Ingles M, Molla-Casanova S, Sempere-Rubio N, Serra-Ano P, Aguilar-Rodriguez M. Effects of an Oral Stimulation Program on Feeding Outcomes in Preterm Infants: A Systematic Review and Meta-Analysis. Phys Occup Ther Pediatr. 2024;44(1):110-127. doi: 10.1080/01942638.2023.2212767. Epub 2023 May 18.

  PMID: 37203152 BACKGROUND

• Zhao S, Jiang H, Miao Y, Liu W, Li Y, Zhang Y, Wang A, Cui X. Effects of implementing non-nutritive sucking on oral feeding progression and outcomes in preterm infants: A systematic review and meta-analysis. PLoS One. 2024 Apr 16;19(4):e0302267. doi: 10.1371/journal.pone.0302267. eCollection 2024.

  PMID: 38626172 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Serdar Beken

  Acibadem University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zehra Kan Öntürk, Assoc.Prof.

CONTACT

0265004163; zehrakan@gmail.com

Zehra Kan Öntürk, Assoc.Prof.

CONTACT

02165004163; zehrakan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 9, 2025
• Study Start: March 4, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)