Effects of a Valved Feeding System in Late-preterm Newborns: the Safe Oral Feeding Trial (SOFT)

August 15, 2023 updated by: Francesco Cresi, MD, PhD, University of Turin, Italy

Effects on Coordination of Sucking, Swallowing and Breathing Process of a Valved Feeding System in Late-preterm Newborns. The Safe Oral Feeding Trial (SOFT)

Comparing with a randomized controlled trial two different feeding systems in two groups of late-preterm newborns for evaluating which is more efficient in promoting the coordination in the process of sucking-swallowing-breathing and better cardiorespiratory stability.

The B-ESP group will be fed with a feeding system with a valved ergonomic teat; the B-STD with a standard feeding system.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The swallowing patterns are still immature in the newborn, especially if preterm. An incomplete synchronization in the process of sucking, swallowing and breathing could lead to some difficulty during feedings with desaturations and risk of milk inhalation in the upper airway tract. Moreover, a dysfunctional or immature pattern of sucking, swallowing and breathing also affect the post-prandial period, tiring the newborn and increasing the cardio-respiratory instability.

Breastfeeding promote the development of a physiological coordination of the process of sucking, swallowing and breathing, guaranteeing high and stable values of oxygenation during feedings. On the other hand, bottle-feeding could be responsible of a difficult coordination among the phases of swallowing and breathing. In an healthy, at term, brestfed newborn is observed a typical pattern of sucking-swallowing-expiration with a ratio of 1:1:1. In a bottlefed newborn this ratio is 2-12:1:4, with a relative increase of the period of sucking compared to the swallowing one, that could lead to apnoeas and desaturations.

The differences between the two feedings modality are more accentuated in the late-preterm newborn, which is more prone to cardio-respiratory instability compared to the healthy at term newborn, because of the immaturity of the respiratory centers in the brainstem, and of the processes responsible for the coordination of the sucking, swallowing and breathing .

However breastfeeding, in spite of the fact that is crucial for the development of the correct process of sucking, can be challenging in the premature infant because it requires a considerable physical effort.

Therefore, disposing of devices for nutrition able to facilitate oral feeding, simulating the physiologic breastfeeding, is necessary. In this way, we can contribute to the development of the proper sucking-swallowing-breathing pattern and to improve cardio-respiratory stability.

In literature there are multiple studies carried out on term newborns demonstrating the importance of the negative pressure or air vacuum created in the oral cavity, in order to promote the emptying of the lactiferous ducts and/or of the teat and simultaneously promote the maintainance of the right respiratory pattern. An ergonomic feeding system with a valve able to create vacuum could be able to respond to the demands of late preterm newborns.

Aim of the study is to evaluate the effects of a trial with an experimental feeding system with a teat with a valve able to facilitate the vacuum in the oral cavity on the pattern of sucking-swallowing and breathing in late preterm newborns.

NUMBER OF PATIENTS Precise data regarding swallowing/respiration rate in bottle-fed late preterm infants in the first 3 days of life are lacking in the literature. Considering a mean swallow/respiration ratio of 1.5 and a variance of 0.5, obtained from surveys performed at our center prior to the study, a sample size of 38 infants per arm was estimated to achieve 80% power to detect a 30% difference on the primary outcome with a significance level of 0.05.

STUDY DESIGN Late preterm newborns eligible to enter in the study, prior obtaining the informed consent from parents, will be assigned in the "B-ESP" or "B-STD" group through a process of block randomisation, controlled by a software.

Newborns included in the randomisation, after a training of 3 meals with the feeding bottle assigned from the randomisation, can be entered in the study.

Newborns included in the study will be monitored for the entire duration of a meal and the subsequent 3-hours period. This monitoring will be collected in two different times (T1 and T2): in the second day of life (24-48 hours of life) and in the fourth day of life (72-96 hours of life). The study includes an audio recording of the swallowings through a microphone in the room and the recordings of the process of sucking and swallowing through a cutaneous sensor.

In addition, a cardiorespiratory monitoring with a poligraph will be made, considering oxygen saturation, cardiac and respiratory frequency and electrocardiography. The meal's video recording will permit a subsequent classification of the sucking movements and the evaluation of any possible interference in the polygraphic recording.

FEEDING DEVICES

Newborns of the B-STD group will be fed using a classic disposable feeding device, which is actually in use in our centre and provided by our hospital, composed of:

  • a 150 mL feeding bottle in polypropylene, devoid of BPA;
  • a silicon teat, devoid of BPA, available in two types, (a slow graduated flow and a standard flow) depending on the necessities and suction abilities of the baby;
  • a protective plug.

Newborns of the B-ESP group will be fed using a feeding system with a valved ergonomic teat, composed of:

  • a slow-flow ergonomic silicon teat
  • polipropilene bottle with a capacity of 150 mL, with a ventilation valve on the bottom
  • silicon valve

Newborns will be fed with defined quantities of maternal milk or bank donated milk, based on weight and gestational age.

The meal will be administered by the caregiver (a parent or a nurse) previously trained. The meal's administration will be performed keeping the baby in the caregivers's arms in the ESL position (semielevated side-lying). At the end of the feeding process the newborn will be repositioned in his cradle in the supine position.

The cardiosaturimetric evaluation will be performed using a system of polygraphic monitoring, which allows a simultaneous non-invasive recording of cardiorespiratory parameters, noises and movements associated to the sucking and swallowing processes combined to video recordings.

The evaluation of the sucking process will be carried out using a structured questionnaire composed by 31 items, which allows to distinguish normal suction (mature) from disorganized and dysfunctional ones.

Considering simultaneously the cardiosaturimetric parameters, video, audio and cutaneous sensor's recordings, it is possible to obtain a more accurate evaluation of the processes of swallowing, sucking and breathing of the newborn during meal administration. It is also possible to identify the exact moment of the breathing process assigned to the newborn's swallowing.

CLINICAL DATA

At birth:

  • gestational age;
  • weight in grams;
  • z-score;
  • sex;
  • type of delivery;
  • peri-partum condition, including possible administration of prenatal corticosteroids;
  • type of support provided at birth;

At T1 and T2:

  • hours from birth;
  • weight;
  • z-score;
  • number of meals in a day;
  • type of milk administered;
  • overall volume administered expressed in mL in a day;
  • duration of a meal expressed in minutes;
  • number of regurgitation or vomit during the administration of a meal;
  • number of regurgitation or vomit after the admninistration of a meal;

At discharge:

  • weight;
  • z-score;
  • number of meals in a day;
  • type of feeding (exclusive breastfeeding; exckusive bottlefeeding or mixed)
  • overall volume administered expressed in mL in a day;

INSTRUMENTAL DATA

  • Number of suctions;
  • Number of swallowings;
  • Number of apnoeas;
  • Average duration of apnoeas;
  • Number of oxygen desaturations
  • Minimal oxygen saturation;
  • Number of reduction of cardiac frequency (bradycardia);
  • Minimal cardiac frequency. The definition of apnoea, oxygen desaturation and bradycardia applied in this study are the ones defined by literature (Di Fiore JM, Arko MK, Miller MJ, et al. Cardiorespiratory Events in Preterm Infants Referred for Apnea Monitoring Studies. PEDIATRICS. 2001;108(6):1304-1308.)
  • APNOEA: arrest of the breathing acts for a period of at least 20 seconds or arrest of the breathing acts for a period of at least 5 seconds associated with bradycardia and/or desaturations;
  • OXYGEN DESATURATIONS: reduction of the oxygen saturation (SpO2) <80% or of at least 5% compared to the baseline, for at least 4 seconds.
  • BRADYCARDIA: reduction of the cardiac frequency under 80 bpm for at least 4 seconds

STATISTICAL ANALYSIS

Statistical analysis will be carried out using the STATISTICA software package for Windows (StatSoft, Inc., Tulsa, Oklahoma, USA). Every newborn in the experimental group will be matched with a newborn of the control group similar for gestational age and weight. For the normal distribution, data will be tested with the Kolmogorov-Smirnov test and with the exploratory data analysis. Data will be expressed as statistical mean and standard deviation (SD) or as median and interquantile range depending on the relative distribution. The differences between the polisonnographic data will be evaluated with the Student's T test or through a similar non-parametric test depending on the distribution: Fisher test for comparison between categorical data and regression tests (linear and non-linear) for comparison between continuous variables. Statistical significance is set as p<0.05.

EXPECTED RESULTS

The more physiological administration of milk with a feeding system with a valved ergonomic teat, could better promote the development of coordination in the process of sucking-swallowing-breathing. Therefore inhalation and cardiosaturimetric events during a meal and immediately after will be reduced and therefore the newborn's oral feeding tolerance will increase, making it more similar to physiological breastfeeding.

Bottle-feeding milk administration with a feeding system with a valved ergonomic teat in the first days of life, the period when exclusive breastfeeding is more difficult, could also promote the transition between bottle-feeding to breastfeeding, because this mechanism is more similar to the physiological one.

If the results of this study will support this hypotesis, feeding system with a valved ergonomic teat could be chosen as a non-pharmacological treatment for late-preterm newborns who encounter difficulty in the oral feeding, such as cardio-respiratory instability during the sucking process and risk of milk inhalation when the breastfeeding is not possible.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Turin, Italy, 10126
        • Città della Salute e della Scienza - Ospedale S.Anna - University of Turin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 5 days (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Gestational age 34+0 - 36+6 weeks at birth;
  • Exclusive oral feeding;
  • Bottle-feeding for at least a meal a day;

Exclusion Criteria:

  • Newborns with exclusive breastfeeding;
  • Newborns with congenital anomalies, perinatal asphyxia, respiratory or neurological issues, genetic syndromes, infections, metabolic diseases;
  • Ongoing administration of medication able to interfere with esophageal or respiratory function;
  • Newborns who require respiratory support, including oxygen-therapy via nasal-cannula;
  • Newborns who require oral or nasal feeding tube;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: B-ESP
B-ESP group will be fed with a feeding system with a valved ergonomic teat.
Device: Valved ergonomic teat
Administration of milk with a feeding system with a valved ergonomic teat in late preterm newborns.
Sham Comparator: B-STD
B-STD will be fed with a standard feeding system.
Device: Standard silicon teat
Administration of milk with a feeding system with a standard silicon teat

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluating the level of coordination in the sucking-swallowing-breathing pattern in the B-ESP group compared with the B-STD
Time Frame: Calculated throughout 72 hours

This evaluation will be recorded at 24 and 72 hours of life and defined from the suckings/swallowings ratio.

The literature describes this parameter as strongly associated to a higher maturity of the sucking-swallowing-breathing pattern; in fact, a ratio of sucking-swallowing-breathing of 1:1:1 describes the mature pattern, typical of the breastfeeding and considered the optimum for a newborn.
Calculated throughout 72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coefficient of variation of time between sucking and swallowing
Time Frame: Calculated throughout 72 hours
This coefficient is expressed in seconds. a lower coefficient corresponds to breastfeeding
Calculated throughout 72 hours
Mean percentage of incidence of breaths that precede and follow the swallowings
Time Frame: Calculated throughout 72 hours
This percentage is classified by Lau et al. (the average interval between two breathing acts monitored during a meal of an healthy at term newborn varies between 1.2-2 seconds)
Calculated throughout 72 hours
Evaluation of the sucking processes
Time Frame: Calculated throughout 72 hours
This evaluation is made through the a structured questionnaire composed by 31 items
Calculated throughout 72 hours
Evaluation of cardiorespiratory stability
Time Frame: Calculated throughout 72 hours
This evaluation is made considering frequency and characteristics of cardiorespiratory events (during and after meal administration)
Calculated throughout 72 hours
Evaluation of meal tolerance
Time Frame: Calculated throughout 72 hours
This evaluation is carried out considering the number of vomiting and regurgitations during and after the meal, volume in mL per meal, number of meals per day
Calculated throughout 72 hours
Number of breastfed newborns at the time of dimission
Time Frame: Calculated throughout 72 hours
Calculated throughout 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turin, Italy

Investigators

  • Principal Investigator: Francesco Cresi, MD; PhD, Città della Salute e della Scienza - Ospedale S.Anna - University of Turin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

May 31, 2023

Study Completion (Actual)

May 31, 2023

Study Registration Dates

First Submitted

April 25, 2020

First Submitted That Met QC Criteria

May 19, 2020

First Posted (Actual)

May 22, 2020

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 15, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOFT-study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Premature Birth

Clinical Trials on Valved ergonomic teat

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe