Premature InfantNCT07060573
Effects of Oral Stimulation Performed by Parents to Improve Sucking in Neonates Hospitalized in the NICU
A study testing Parental Oral Stimulation Protocol and Physiotherapist-led Oral Stimulation in people with Premature Infant and Sucking Behavior, run by Hospital Civil de Guadalajara at 1 site in Mexico.
Trial summary
This randomized clinical trial aims to evaluate the effectiveness of an oral stimulation program to improve sucking in preterm neonates hospitalized in the NICU. The study compares two groups: one receiving the intervention from a physiotherapist and the other from trained parents. Read more about this study
- Who is it for?
- Ages 34 to 36 weeks
- Conditions the study is for
- Premature Infant, Sucking Behavior
- What is being tested?
- Parental Oral Stimulation Protocol and Physiotherapist-led Oral Stimulation
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteMexico
- Study dates
- 18 Jul 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 34 to 36 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates with corrected gestational age of 34 to 36 weeks
- Clinically stable to receive oral stimulation
- Informed consent obtained from parents or legal guardians
Who cannot join
- Orofacial congenital malformations
- Severe neuromuscular disease
- Conditions contraindicating oral feeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Antiguo Hospital Civil Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, 44280
José Armando Labra Zepeda, fellow, +523313249586, drjosearmandolz@gmail.com
Nelsi Alejandra González González, subspecialty, +523312567344, nagonzalez@hcg.gob.mx
About this study
Official title: Effects of Oral Stimulation Performed by Parents to Improve Sucking in Neonates Hospitalized in the NICU: A Randomized Clinical Trial
This randomized clinical trial aims to evaluate the effectiveness of an oral stimulation program to improve sucking in preterm neonates hospitalized in the NICU. The study compares two groups: one receiving the intervention from a physiotherapist and the other from trained parents. The stimulation program includes 4 extraoral and 4 intraoral exercises applied once daily for 14 consecutive days. The primary outcome is improvement in the POFRAS score. Secondary outcomes include the time to exclusive oral feeding, nasogastric tube withdrawal, weight at discharge, hospital stay duration, and parental adherence. This study addresses the potential role of parent participation in neonatal rehabilitation in public hospitals with limited human resources.
Read the detailed description
This single-blind, randomized clinical trial aims to compare the effectiveness of oral rehabilitation performed by trained parents versus physiotherapists to improve sucking in preterm neonates hospitalized in the NICU at the Hospital Civil de Guadalajara "Fray Antonio Alcalde," during the period July-October 2025.
Eligible neonates will be randomized into two groups:
Group A (Control): Intervention performed daily by a trained physiotherapist.
Group B (Experimental): Intervention performed daily by the parents after structured training and supervised implementation.
The oral stimulation program consists of 4 extraoral and 4 intraoral exercises designed to promote the development of sucking, swallowing, and breathing coordination. Each session lasts approximately 15 minutes and will be applied once daily for 14 consecutive days or until full oral feeding is achieved.
The primary outcome will be improvement in oral feeding readiness, assessed using the validated Spanish version of the POFRAS (Preterm Oral Feeding Readiness Assessment Scale). Secondary outcomes include: achievement of exclusive oral feeding, time to withdrawal of nasogastric tube, weight gain, hospital length of stay, and parent adherence to the protocol.
Randomization will use permuted blocks, and the outcome assessor will be blinded to group assignment. This study explores the feasibility and impact of parent-administered interventions in a public hospital setting with limited specialized personnel.
- Conditions
- Premature Infant, Sucking Behavior
- Being tested
- Parental Oral Stimulation Protocol, Physiotherapist-led Oral Stimulation
- Keywords
- Premature infant, sucking, oral stimulation, POFRAS, NICU, feeding, physiotherapy, Rehabilitation, parental involvement
- Medical subject headings
- Premature Birth, Sucking Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parental Oral Stimulation ProtocolBehavioural
This intervention consists of a structured oral stimulation protocol composed of 4 extraoral and 4 intraoral exercises designed to improve oral motor function in preterm neonates. Exercises include perioral massage, stimulation of sucking reflex, and non-nutritive sucking using a pacifier. The protocol is administered once daily for 14 consecutive days. In this study arm, the intervention is performed by parents, previously trained and supervised in the neonatal unit.
Physiotherapist-led Oral StimulationBehavioural
This intervention consists of a structured oral stimulation protocol composed of 4 extraoral and 4 intraoral exercises designed to improve oral motor function in preterm neonates. Exercises include perioral massage, stimulation of sucking reflex, and non-nutritive sucking using a pacifier. The protocol is administered once daily for 14 consecutive days. In this study arm, the intervention is performed by a licensed physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Parental Oral Stimulation Intervention | Experimental | Parents are trained to perform a standardized oral stimulation protocol (4 extraoral and 4 intraoral exercises) once daily for 14 days. Receives: Behavioral: Parental Oral Stimulation Protocol |
| Physiotherapist-led Oral Stimulation | Active comparator | A licensed physiotherapist performs the same standardized oral stimulation protocol once daily for 14 days Receives: Behavioral: Physiotherapist-led Oral Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in POFRAS Score from Day 1 to Day 14
Change in the total score of the POFRAS scale (0-36 points), which evaluates oral feeding readiness in preterm neonates. A higher score indicates greater readiness for oral feeding.
Measured: Baseline and Day 14 of intervention
Secondary outcomes (4)
Time to Exclusive Oral Feeding
Number of days required for the neonate to transition from tube feeding to exclusive oral feeding without need for nasogastric support.
Measured: From baseline to achievement of full oral feeding (up to 14 days)
Weight at Hospital Discharge
Body weight in grams recorded at the time of NICU discharge
Measured: Baseline and Day 14 post-intervention
Length of Hospital Stay
Total number of days the neonate remains hospitalized in the neonatal intensive care unit (NICU) until medically cleared for discharge.
Measured: From birth until hospital discharge, assessed up to 60 days
Parental Satisfaction
Level of parental satisfaction with the intervention protocol, assessed using a 5-point Likert scale (1 = very dissatisfied; 5 = very satisfied).
Measured: At Day 14 or end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start18 Jul 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Civil de Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nelsi Alejandra Gonzalez Gonzalez, Hospital Civil de Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060573
- Sponsor's protocol ID
- CEI 149/25
- Status last verified
- Feb 2026
- First submitted
- 24 Jun 2025
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time, there is no plan to share individual participant data (IPD) due to institutional data privacy policies and the absence of a secure data-sharing infrastructure. Data will remain confidential and stored locally, in compliance with ethical and regulatory standards.
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Stimulation Performed by Parents to Improve Sucking in Neonates Hospitalized in the NICU: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07060573
- Acronym / sponsor ID
- CEI 149/25
- Conditions
- Premature Infant, Sucking Behavior
- Keywords
- Premature infant, sucking, oral stimulation, POFRAS, NICU, feeding, physiotherapy, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Hospital Civil de GuadalajaraUniversity, hospital or other
- Study start
- 18 Jul 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized clinical trial aims to evaluate the effectiveness of an oral stimulation program to improve sucking in preterm neonates hospitalized in the NICU. The study compares two groups: one receiving the intervention from a physiotherapist and the other from trained parents. The stimulation program includes 4 extraoral and 4 intraoral exercises applied once daily for 14 consecutive days. The primary outcome is improvement in the POFRAS score. Secondary outcomes include the time to exclusive oral feeding, nasogastric tube withdrawal, weight at discharge, hospital stay duration, and parental adherence. This study addresses the potential role of parent participation in neonatal rehabilitation in public hospitals with limited human resources.
Detailed description
This single-blind, randomized clinical trial aims to compare the effectiveness of oral rehabilitation performed by trained parents versus physiotherapists to improve sucking in preterm neonates hospitalized in the NICU at the Hospital Civil de Guadalajara "Fray Antonio Alcalde," during the period July-October 2025.
Eligible neonates will be randomized into two groups:
Group A (Control): Intervention performed daily by a trained physiotherapist.
Group B (Experimental): Intervention performed daily by the parents after structured training and supervised implementation.
The oral stimulation program consists of 4 extraoral and 4 intraoral exercises designed to promote the development of sucking, swallowing, and breathing coordination. Each session lasts approximately 15 minutes and will be applied once daily for 14 consecutive days or until full oral feeding is achieved.
The primary outcome will be improvement in oral feeding readiness, assessed using the validated Spanish version of the POFRAS (Preterm Oral Feeding Readiness Assessment Scale). Secondary outcomes include: achievement of exclusive oral feeding, time to withdrawal of nasogastric tube, weight gain, hospital length of stay, and parent adherence to the protocol.
Randomization will use permuted blocks, and the outcome assessor will be blinded to group assignment. This study explores the feasibility and impact of parent-administered interventions in a public hospital setting with limited specialized personnel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parental Oral Stimulation Intervention | Experimental | Behavioral: Parental Oral Stimulation ProtocolParents are trained to perform a standardized oral stimulation protocol (4 extraoral and 4 intraoral exercises) once daily for 14 days. |
| Physiotherapist-led Oral Stimulation | Active comparator | Behavioral: Physiotherapist-led Oral StimulationA licensed physiotherapist performs the same standardized oral stimulation protocol once daily for 14 days |
Who may qualify
- Ages
- 34 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Neonates with corrected gestational age of 34 to 36 weeks
- Clinically stable to receive oral stimulation
- Informed consent obtained from parents or legal guardians
Key exclusion criteria (3 listed)
- Orofacial congenital malformations
- Severe neuromuscular disease
- Conditions contraindicating oral feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parental Oral Stimulation ProtocolThis intervention consists of a structured oral stimulation protocol composed of 4 extraoral and 4 intraoral exercises designed to improve oral motor function in preterm neonates. Exercises include perioral massage, stimulation of sucking reflex, and non-nutritive sucking using a pacifier. The protocol is administered once daily for 14 consecutive days. In this study arm, the intervention is performed by parents, previously trained and supervised in the neonatal unit. | Behavioural | Parental Oral Stimulation Intervention |
| Physiotherapist-led Oral StimulationThis intervention consists of a structured oral stimulation protocol composed of 4 extraoral and 4 intraoral exercises designed to improve oral motor function in preterm neonates. Exercises include perioral massage, stimulation of sucking reflex, and non-nutritive sucking using a pacifier. The protocol is administered once daily for 14 consecutive days. In this study arm, the intervention is performed by a licensed physiotherapist. | Behavioural | Physiotherapist-led Oral Stimulation |
Primary outcome
Change in POFRAS Score from Day 1 to Day 14
Time frame: Baseline and Day 14 of intervention
Change in the total score of the POFRAS scale (0-36 points), which evaluates oral feeding readiness in preterm neonates. A higher score indicates greater readiness for oral feeding.
4 secondary outcomes
Time to Exclusive Oral Feeding
Time frame: From baseline to achievement of full oral feeding (up to 14 days)
Weight at Hospital Discharge
Time frame: Baseline and Day 14 post-intervention
Length of Hospital Stay
Time frame: From birth until hospital discharge, assessed up to 60 days
Parental Satisfaction
Time frame: At Day 14 or end of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No. At this time, there is no plan to share individual participant data (IPD) due to institutional data privacy policies and the absence of a secure data-sharing infrastructure. Data will remain confidential and stored locally, in compliance with ethical and regulatory standards.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parental Oral Stimulation Protocol and Physiotherapist-led Oral Stimulation in people with Premature Infant and Sucking Behavior, run by Hospital Civil de Guadalajara at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nelsi Alejandra Gonzalez Gonzalez, subspecialty (+5213312567344, ngonzalez@hcg.gob.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in POFRAS Score from Day 1 to Day 14 (time frame: Baseline and Day 14 of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.