Feeding DifficultiesPIOMINCT07460089
Premature Infant Oral Motor Intervention vs. Pacifier for Oral Feeding Transition in Preterm Infants
A study testing Premature Infant Oral Motor Intervention (PIOMI) and Pacifier Use (Non-Nutritive Sucking) in people with Feeding Difficulties and Sucking Behavior, run by University of Baghdad at 1 site in Iraq.
Trial summary
This study compares three approaches to help premature babies learn to feed by mouth: a special mouth exercise program (called PIOMI), using a pacifier, and standard care. Premature babies often have difficulty feeding because their sucking, swallowing, and breathing are not yet coordinated, which can lead to longer… Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Feeding Difficulties, Sucking Behavior, Premature
- What is being tested?
- Premature Infant Oral Motor Intervention (PIOMI) and Pacifier Use (Non-Nutritive Sucking)
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIraq
- Study dates
- 10 Mar 2026to 30 May 2026
- 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 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- - Preterm infants born at 26-32 weeks of gestational age
- - Clinically stable (no mechanical ventilation, no major congenital anomalies, no necrotizing enterocolitis)
- - Birth weight ≥1000 grams
- - Informed consent obtained from parents or legal guardians
Who cannot join
- Orofacial malformations (e.g., cleft lip, cleft palate)
- Neurological impairment affecting sucking ability (e.g., intraventricular hemorrhage grade III or IV, periventricular leukomalacia)
- Infants who received any prior structured oral motor intervention
- Major congenital anomalies or genetic syndromes affecting feeding or development
- Infants requiring surgical interventions during the study period
- Lack of parental consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq1 site
Al-Habobi Teaching Hospital
Nasiriyah, Thi Qar
Zaid W Ajel, PhD, Associate Professor, +9647727479781, zaid_ahjil@conursing.uobaghdad.edu.iq
About this study
Official title: The Effect of the Premature Infant Oral Motor Intervention Versus Pacifier Use in the Transition to Oral Feeding in Preterm Infants
This study compares three approaches to help premature babies learn to feed by mouth: a special mouth exercise program (called PIOMI), using a pacifier, and standard care. Premature babies often have difficulty feeding because their sucking, swallowing, and breathing are not yet coordinated, which can lead to longer hospital stays. The study will include 150 premature infants born between 26 and 32 weeks of pregnancy at a hospital in Thi Qar. Babies will be randomly placed into one of three groups: one group will receive a many-day mouth exercise program, another will use a pacifier for many days, and the third will receive routine care. We will measure how quickly each baby learns to feed fully by mouth, how long they stay in the hospital, how much weight they gain, and their feeding skills. The results may help improve care for premature babies and reduce the time they spend in the hospital.
Read the detailed description
Detailed Description:
Preterm birth, defined as delivery before 37 weeks of gestation, affects approximately 10% of live births worldwide and constitutes a major public health challenge. One of the most critical milestones for preterm infants in the neonatal intensive care unit (NICU) is the acquisition of safe and efficient oral feeding. This skill requires coordinated sucking, swallowing, and breathing - a neurodevelopmental process that typically matures only after 34-36 weeks postmenstrual age. Delayed attainment of full oral feeding prolongs hospitalization, increases healthcare costs, and exposes infants to risks such as nosocomial infections and parental psychological distress (Perin et al., 2022; Ibrahim et al., 2024).
The theoretical framework underpinning this study is the "experience-dependent neuroplasticity" model, which posits that structured sensorimotor experiences can accelerate neural pathway development. The Premature Infant Oral Motor Intervention (PIOMI) is a structured, evidence-based protocol designed to provide such experience. It consists of gentle stimulation of the perioral and intraoral structures, including cheeks, lips, gums, tongue, and palate, followed by facilitation of non-nutritive sucking movements. The intervention is delivered in eight sequential steps: (1) cheek C-stretch, (2) lip roll, (3) lip stretch, (4) gum massage, (5) lateral tongue stretch, (6) mid-tongue and palate massage, (7) suck reflex stimulation, and (8) non-nutritive sucking. Each session lasts 5-10 minutes, performed with the infant in a midline chin-tuck position under controlled environmental conditions (dim light, minimal noise). Trained nurses monitor stress cues throughout the procedure to ensure safety. Previous studies have reported that PIOMI may shorten the time to independent oral feeding by 6-13 days and improve weight gain (Thabet \& Sayed, 2021; Sasmal et al., 2025).
Non-nutritive sucking via a pacifier is a simpler, widely used intervention that may enhance sucking organization through repetitive oromotor activity and provide calming effects via parasympathetic activation. However, robust comparative data between PIOMI and pacifier use are lacking, particularly from adequately powered randomized trials. A recent pilot study by Cakirli et al. (2025) highlighted this gap, noting that small sample sizes (n=13 per group) limit the generalizability of findings. The present trial addresses this gap by enrolling a larger cohort and employing rigorous methodology.
This single-center, three-arm parallel-group trial will be conducted in the NICU of a major teaching hospital in Baghdad, Iraq, reflecting the local preterm population and clinical practices. Participants will be randomly assigned to one of three groups: PIOMI (7-day protocol), pacifier use (7-day non-nutritive sucking), or routine care (standard NICU feeding support). Blinding of participants and care providers is not feasible due to the nature of the interventions; however, outcome assessors responsible for measuring feeding milestones and weight will be masked to group assignment to minimize detection bias.
The study's conceptual framework integrates physiological, developmental, and clinical perspectives to evaluate how structured oromotor stimulation influences feeding outcomes. By comparing two active interventions with routine care, the trial aims to identify the most effective strategy for facilitating oral feeding in preterm infants, thereby potentially reducing hospitalization duration and improving long-term developmental outcomes.
All procedures will be conducted in accordance with the Declaration of Helsinki and local regulatory requirements. Written informed consent will be obtained from parents or legal guardians before enrollment.
- Conditions
- Feeding Difficulties, Sucking Behavior, Premature
- Being tested
- Premature Infant Oral Motor Intervention (PIOMI), Pacifier Use (Non-Nutritive Sucking)
- Keywords
- Premature Infant, Preterm Infant, Oral Feeding, Feeding Difficulties, Sucking Behavior, PIOMI, Pacifier Use, Non-nutritive Sucking, Oral Motor Intervention, Neonatal Intensive Care, NICU, Feeding Transition, Weight Gain, Length of Hospital Stay
- Medical subject headings
- Sucking Behavior, Premature Birth, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Premature Infant Oral Motor Intervention (PIOMI)Behavioural
A structured, evidence-based protocol of perioral and intraoral stimulation administered once daily for 7 consecutive days (5-10 minutes per session). The protocol includes systematic stimulation of the cheeks, lips, gums, tongue, and palate, followed by facilitation of sucking movements. The intervention is initiated once the infant is medically stable (typically 29-32 weeks postmenstrual age) to enhance oromotor function, improve coordination of sucking-swallowing-breathing, and accelerate the transition to full oral feeding.
Pacifier Use (Non-Nutritive Sucking)Device
Provision of a standard silicone pacifier for non-nutritive sucking. The pacifier is offered during gavage feeding sessions and at times when the infant is awake and calm, for approximately 5-10 minutes per session, once daily for 7 consecutive days. This intervention is initiated once the infant is medically stable (typically 29-32 weeks postmenstrual age) and is provided without any additional structured oral stimulation. The objective is to evaluate the effect of passive sucking on oral feeding readiness and organization.
| Study group | Role | What they receive |
|---|---|---|
| Premature Infant Oral Motor Intervention (PIOMI) Group | Experimental | Premature Infant Oral Motor Intervention (PIOMI) Group The PIOMI group is the experimental arm receiving a structured, evidence-based oral motor stimulation program. This standardized intervention is initiated once the infant is medically stable, typically between 29-32 weeks postmenstrual age. It is administered once daily for 7 consecutive days, with each session lasting 5-10 minutes. The protocol includes systematic stimulation of perioral and intraoral structures (cheeks, lips, gums, tongue, and palate) and facilitation of sucking movements. The objective is to enhance oromotor function, improve coordination of sucking-swallowing-breathing, and accelerate the transition to full oral feeding, thereby reducing hospital stay. Receives: Behavioral: Premature Infant Oral Motor Intervention (PIOMI) |
| Pacifier Use Group | Active comparator | This group serves as the active comparator arm, receiving non-nutritive sucking (NNS) via a standard pacifier. The intervention is initiated once the infant is medically stable, typically between 29-32 weeks postmenstrual age, consistent with the PIOMI group timeline. Pacifier use is provided during gavage feeding sessions and at times when the infant is awake and calm, for approximately 5-10 minutes per session, once daily for 7 consecutive days. The pacifier is offered without additional oral stimulation. The objective is to evaluate the effect of pacifier-based NNS on oral feeding readiness, sucking organization, and transition to full oral feeding compared to the structured PIOMI protocol and routine care. This comparator allows differentiation between passive sucking effects and active oromotor stimulation. Receives: Device: Pacifier Use (Non-Nutritive Sucking) |
| control group | No intervention | Control Group (No Intervention) This group serves as the control arm, receiving routine neonatal care without any structured oral motor intervention or protocol-driven pacifier use. Infants in this group receive standard care as per the neonatal intensive care unit (NICU) protocol, including gavage feeding, gradual introduction of oral feeding based on clinical readiness, and routine nursing care. Pacifiers may be used sporadically at the discretion of nursing staff or parents, but not as part of a structured protocol. The objective is to establish a baseline for comparison with the PIOMI and pacifier groups, allowing assessment of the natural progression of oral feeding skills and the specific effects of the active interventions on feeding outcomes, growth, and hospital stay duration. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Achieve Full Oral Feeding
Time to Achieve Full Oral Feeding
Measure Description:
The number of days from the start of the intervention to the first 24-hour period of exclusive oral feeding (defined as consuming ≥120 mL/kg/day without tube supplementation).
Time Frame:
From start of intervention until achievement of full oral feeding (up to hospital discharge, approximately 8 weeks)
Measured: From start of intervention until achievement of full oral feeding (up to hospital discharge, approximately 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start10 Mar 2026 (estimated)
- Primary completion20 Apr 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Feeding DifficultiesStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study employs a parallel assignment design with three arms: 1. PIOMI Group - receives structured oral motor stimulation for 7-10 days. 2. Pacifier Group - receives non-nutritive sucking via pacifier for 7-10 days. 3. Control Group - receives routine NICU care only. A total of 150 preterm infants (gestational age 26-32 weeks) will be randomly assigned in a 1:1:1 ratio using a simple lottery method. Allocation is concealed by sequentially numbered, opaque, sealed envelopes. Participants are enrolled at a single center (teaching hospital NICU in Baghdad, Iraq) and remain in their assigned group throughout the study. Interventions are initiated once the infant is clinically stable. The primary outcome is time to achieve full oral feeding (≥120 mL/kg/day for 24 h). Secondary outcomes include hospital stay, weight gain, feeding efficiency, and early feeding skills. Outcome assessors are blinded to group assignment to minimize detection bias.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laith Abd AL-Karim Hani, University of Baghdad
- Investigators
- Zaid W Ajel, PhD, Assoc Prof, Principal investigator, University of Baghdad / College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460089
- Sponsor's protocol ID
- PIOMI-2025-001
- Other IDs
- Other Identifier, Approval Number:66
- Acronym
- PIOMI
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study does not plan to share individual participant data (IPD) with other researchers due to the following reasons: * Data Sensitivity: The study involves a vulnerable population (preterm infants), and the informed consent obtained from parents does not include provisions for sharing raw data beyond this research. * Single-Center Context: As a two -center master's thesis conducted in Iraq, the data are context-specific and may not be generalizable to other populations without appropriate validation. * Lack of Infrastructure: No established data repository, resources, or funding are available for anonymizing, storing, or sharing IPD. Confidentiality Concerns: Maintaining participant confidentiality and complying with local ethical regulations take precedence over data sharing. Publication Plans: Aggregate results will be published in peer-reviewed journals and presented at conferences, fulfilling dissemination requirements without sharing individual-level data.
Publications
Perin J, Mulick A, Yeung D, Villavicencio F, Lopez G, Strong KL, Prieto-Merino D, Cousens S, Black RE, Liu L. Global, regional, and national causes of under-5 mortality in 2000-19: an updated systematic analysis with implications for the Sustainable Development Goals. Lancet Child Adolesc Health. 2022 Feb;6(2):106-115. doi: 10.1016/S2352-4642(21)00311-4. Epub 2021 Nov 17.
PubMed 34800370
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Premature Infant Oral Motor Intervention Versus Pacifier Use in the Transition to Oral Feeding in Preterm Infants
- ClinicalTrials.gov ID
- NCT07460089
- Acronym / sponsor ID
- PIOMI / PIOMI-2025-001
- Conditions
- Feeding Difficulties, Sucking Behavior, Premature
- Keywords
- Premature Infant, Preterm Infant, Oral Feeding, Feeding Difficulties, Sucking Behavior, PIOMI, Pacifier Use, Non-nutritive Sucking
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 10 Mar 2026 (estimated)
- Primary completion
- 20 Apr 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 10 Mar 2026 (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 study compares three approaches to help premature babies learn to feed by mouth: a special mouth exercise program (called PIOMI), using a pacifier, and standard care. Premature babies often have difficulty feeding because their sucking, swallowing, and breathing are not yet coordinated, which can lead to longer hospital stays. The study will include 150 premature infants born between 26 and 32 weeks of pregnancy at a hospital in Thi Qar. Babies will be randomly placed into one of three groups: one group will receive a many-day mouth exercise program, another will use a pacifier for many days, and the third will receive routine care. We will measure how quickly each baby learns to feed fully by mouth, how long they stay in the hospital, how much weight they gain, and their feeding skills. The results may help improve care for premature babies and reduce the time they spend in the hospital.
Detailed description
Detailed Description:
Preterm birth, defined as delivery before 37 weeks of gestation, affects approximately 10% of live births worldwide and constitutes a major public health challenge. One of the most critical milestones for preterm infants in the neonatal intensive care unit (NICU) is the acquisition of safe and efficient oral feeding. This skill requires coordinated sucking, swallowing, and breathing - a neurodevelopmental process that typically matures only after 34-36 weeks postmenstrual age. Delayed attainment of full oral feeding prolongs hospitalization, increases healthcare costs, and exposes infants to risks such as nosocomial infections and parental psychological distress (Perin et al., 2022; Ibrahim et al., 2024).
The theoretical framework underpinning this study is the "experience-dependent neuroplasticity" model, which posits that structured sensorimotor experiences can accelerate neural pathway development. The Premature Infant Oral Motor Intervention (PIOMI) is a structured, evidence-based protocol designed to provide such experience. It consists of gentle stimulation of the perioral and intraoral structures, including cheeks, lips, gums, tongue, and palate, followed by facilitation of non-nutritive sucking movements. The intervention is delivered in eight sequential steps: (1) cheek C-stretch, (2) lip roll, (3) lip stretch, (4) gum massage, (5) lateral tongue stretch, (6) mid-tongue and palate massage, (7) suck reflex stimulation, and (8) non-nutritive sucking. Each session lasts 5-10 minutes, performed with the infant in a midline chin-tuck position under controlled environmental conditions (dim light, minimal noise). Trained nurses monitor stress cues throughout the procedure to ensure safety. Previous studies have reported that PIOMI may shorten the time to independent oral feeding by 6-13 days and improve weight gain (Thabet \& Sayed, 2021; Sasmal et al., 2025).
Non-nutritive sucking via a pacifier is a simpler, widely used intervention that may enhance sucking organization through repetitive oromotor activity and provide calming effects via parasympathetic activation. However, robust comparative data between PIOMI and pacifier use are lacking, particularly from adequately powered randomized trials. A recent pilot study by Cakirli et al. (2025) highlighted this gap, noting that small sample sizes (n=13 per group) limit the generalizability of findings. The present trial addresses this gap by enrolling a larger cohort and employing rigorous methodology.
This single-center, three-arm parallel-group trial will be conducted in the NICU of a major teaching hospital in Baghdad, Iraq, reflecting the local preterm population and clinical practices. Participants will be randomly assigned to one of three groups: PIOMI (7-day protocol), pacifier use (7-day non-nutritive sucking), or routine care (standard NICU feeding support). Blinding of participants and care providers is not feasible due to the nature of the interventions; however, outcome assessors responsible for measuring feeding milestones and weight will be masked to group assignment to minimize detection bias.
The study's conceptual framework integrates physiological, developmental, and clinical perspectives to evaluate how structured oromotor stimulation influences feeding outcomes. By comparing two active interventions with routine care, the trial aims to identify the most effective strategy for facilitating oral feeding in preterm infants, thereby potentially reducing hospitalization duration and improving long-term developmental outcomes.
All procedures will be conducted in accordance with the Declaration of Helsinki and local regulatory requirements. Written informed consent will be obtained from parents or legal guardians before enrollment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This study employs a parallel assignment design with three arms: 1. PIOMI Group - receives structured oral motor stimulation for 7-10 days. 2. Pacifier Group - receives non-nutritive sucking via pacifier for 7-10 days. 3. Control Group - receives routine NICU care only. A total of 150 preterm infants (gestational age 26-32 weeks) will be randomly assigned in a 1:1:1 ratio using a simple lottery method. Allocation is concealed by sequentially numbered, opaque, sealed envelopes. Participants are enrolled at a single center (teaching hospital NICU in Baghdad, Iraq) and remain in their assigned group throughout the study. Interventions are initiated once the infant is clinically stable. The primary outcome is time to achieve full oral feeding (≥120 mL/kg/day for 24 h). Secondary outcomes include hospital stay, weight gain, feeding efficiency, and early feeding skills. Outcome assessors are blinded to group assignment to minimize detection bias.
| Arm | Type | Receives |
|---|---|---|
| Premature Infant Oral Motor Intervention (PIOMI) Group | Experimental | Behavioral: Premature Infant Oral Motor Intervention (PIOMI)Premature Infant Oral Motor Intervention (PIOMI) Group The PIOMI group is the experimental arm receiving a structured, evidence-based oral motor stimulation program. This standardized intervention is initiated once the infant is medically stable, typically between 29-32 weeks postmenstrual age. It is administered once daily for 7 consecutive days, with each session lasting 5-10 minutes. The protocol includes systematic stimulation of perioral and intraoral structures (cheeks, lips, gums, tongue, and palate) and facilitation of sucking movements. The objective is to enhance oromotor function, improve coordination of sucking-swallowing-breathing, and accelerate the transition to full oral feeding, thereby reducing hospital stay. |
| Pacifier Use Group | Active comparator | Device: Pacifier Use (Non-Nutritive Sucking)This group serves as the active comparator arm, receiving non-nutritive sucking (NNS) via a standard pacifier. The intervention is initiated once the infant is medically stable, typically between 29-32 weeks postmenstrual age, consistent with the PIOMI group timeline. Pacifier use is provided during gavage feeding sessions and at times when the infant is awake and calm, for approximately 5-10 minutes per session, once daily for 7 consecutive days. The pacifier is offered without additional oral stimulation. The objective is to evaluate the effect of pacifier-based NNS on oral feeding readiness, sucking organization, and transition to full oral feeding compared to the structured PIOMI protocol and routine care. This comparator allows differentiation between passive sucking effects and active oromotor stimulation. |
| control group | No intervention | –Control Group (No Intervention) This group serves as the control arm, receiving routine neonatal care without any structured oral motor intervention or protocol-driven pacifier use. Infants in this group receive standard care as per the neonatal intensive care unit (NICU) protocol, including gavage feeding, gradual introduction of oral feeding based on clinical readiness, and routine nursing care. Pacifiers may be used sporadically at the discretion of nursing staff or parents, but not as part of a structured protocol. The objective is to establish a baseline for comparison with the PIOMI and pacifier groups, allowing assessment of the natural progression of oral feeding skills and the specific effects of the active interventions on feeding outcomes, growth, and hospital stay duration. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- - Preterm infants born at 26-32 weeks of gestational age
- - Clinically stable (no mechanical ventilation, no major congenital anomalies, no necrotizing enterocolitis)
- - Birth weight ≥1000 grams
- - Informed consent obtained from parents or legal guardians
Key exclusion criteria (6 listed)
- Orofacial malformations (e.g., cleft lip, cleft palate)
- Neurological impairment affecting sucking ability (e.g., intraventricular hemorrhage grade III or IV, periventricular leukomalacia)
- Infants who received any prior structured oral motor intervention
- Major congenital anomalies or genetic syndromes affecting feeding or development
- Infants requiring surgical interventions during the study period
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 |
|---|---|---|
| Premature Infant Oral Motor Intervention (PIOMI)A structured, evidence-based protocol of perioral and intraoral stimulation administered once daily for 7 consecutive days (5-10 minutes per session). The protocol includes systematic stimulation of the cheeks, lips, gums, tongue, and palate, followed by facilitation of sucking movements. The intervention is initiated once the infant is medically stable (typically 29-32 weeks postmenstrual age) to enhance oromotor function, improve coordination of sucking-swallowing-breathing, and accelerate the transition to full oral feeding. | Behavioural | Premature Infant Oral Motor Intervention (PIOMI) Group |
| Pacifier Use (Non-Nutritive Sucking)Provision of a standard silicone pacifier for non-nutritive sucking. The pacifier is offered during gavage feeding sessions and at times when the infant is awake and calm, for approximately 5-10 minutes per session, once daily for 7 consecutive days. This intervention is initiated once the infant is medically stable (typically 29-32 weeks postmenstrual age) and is provided without any additional structured oral stimulation. The objective is to evaluate the effect of passive sucking on oral feeding readiness and organization. | Device | Pacifier Use Group |
Primary outcome
Time to Achieve Full Oral Feeding
Time frame: From start of intervention until achievement of full oral feeding (up to hospital discharge, approximately 8 weeks)
Time to Achieve Full Oral Feeding Measure Description: The number of days from the start of the intervention to the first 24-hour period of exclusive oral feeding (defined as consuming ≥120 mL/kg/day without tube supplementation). Time Frame: From start of intervention until achievement of full oral feeding (up to hospital discharge, approximately 8 weeks)
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 10 Mar 2026.
- Results publication: PubMed 34800370Perin J, Mulick A, Yeung D, Villavicencio F, Lopez G, Strong KL, Prieto-Merino D, Cousens S, Black RE, Liu L. Global, regional, and national causes of under-5 mortality in 2000-19: an updated systematic analysis with implications for the Sustainable Development Goals. Lancet Child Adolesc Health. 2022 Feb;6(2):106-115. doi: 10.1016/S2352-4642(21)00311-4. Epub 2021 Nov 17.
- Individual participant dataSharing planned: No. This study does not plan to share individual participant data (IPD) with other researchers due to the following reasons: * Data Sensitivity: The study involves a vulnerable population (preterm infants), and the informed consent obtained from parents does not include provisions for sharing raw data beyond this research. * Single-Center Context: As a two -center master's thesis conducted in Iraq, the data are context-specific and may not be generalizable to other populations without appropriate validation. * Lack of Infrastructure: No established data repository, resources, or funding are available for anonymizing, storing, or sharing IPD. Confidentiality Concerns: Maintaining participant confidentiality and complying with local ethical regulations take precedence over data sharing. Publication Plans: Aggregate results will be published in peer-reviewed journals and presented at conferences, fulfilling dissemination requirements without sharing individual-level data.
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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.
Zaid W Ajel, PhD, Assoc Prof principal investigator
University of Baghdad / College of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Premature Infant Oral Motor Intervention (PIOMI) and Pacifier Use (Non-Nutritive Sucking) in people with Feeding Difficulties and Sucking Behavior, run by University of Baghdad at 1 site in Iraq.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 10 Mar 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 Iraq. 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 Laith Abdul Hani, MSc Cand. (+9647801253663, laith.abd2404m@conursing.uobaghdad.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Achieve Full Oral Feeding (time frame: From start of intervention until achievement of full oral feeding (up to hospital discharge, approximately 8 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07460089, which also lists 1 linked publication.
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 10 Mar 2026.