Preventive CarePARENTALIMNCT06184386
Oral Feeding Delay Prevention in Preterm Newborns
An observational study of Preventive Care, run by University Hospital, Caen at 1 site in France.
Trial summary
Preventing oral feeding delays in preterm newborns remains a stake for NICU nowadays. Indeed, it lengthens hospitalization duration, distorts parent-newborns relationships, and increases the risks of adverse nursing outcomes. Read more about this study
- Who is it for?
- Ages 3 days to 10 weeks
- Conditions the study is for
- Preventive Care
- What is being tested?
- NIDCAPARENTALIM and SOFS
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2019to 15 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 3 days to 10 weeks
- All sexes
- Child
Study population: Preterm newborns born before 34 weeks of amenorrhea with variable but moderated neonatal risks and their parents.
Who may be able to join
- Parents of preterm newborns born before 34 weeks of amenorrhea
- Parents who agree participating in the study after signing an informed consent.
- Minimal delay of 72 hours and maximal delay of 15 days after birth to inform parents and wait their consent.
Who cannot join
- Parents of preterm newborns born after 35 weeks of amenorrhea
- Parents who disagree participating in the study, even after signing the informed consent.
- Parents of preterm newborns born with cerebral, maxillo-facial, digestive, cardiac, genetic or syndromic abnormalities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficiency of Parental Feeding Support to Strengthen NIDCAP and Favor Eating Development in Preterm Newborns as Compared With a Retrospective Orofacial Stimulation Standardized and Routine Clinical Practice
Preventing oral feeding delays in preterm newborns remains a stake for NICU nowadays. Indeed, it lengthens hospitalization duration, distorts parent-newborns relationships, and increases the risks of adverse nursing outcomes. Does a routine individualized developmental preventive feeding care implying parents favors earlier autonomous oral feeding achievement in preterm newborns as compared with a standardized routine program of orofacial stimulations, despite neonatal risks that every preterm newborn cumulates during hospitalization stay ?
Read the detailed description
The goal of this observational study is to compare the efficiency of two routine preventive feeding care in preterm newborns, taking into account neonatal cumulated risks for each preterm newborn participant. The main question it aims to answer is: Does a prospective individualized routine developmental preventive feeding care leads to earlier oral feeding achievement in preterm newborns despite individual risks, as compared with a retrospective standardized routine program. The group of preterm newborns prospectively assigned in the study will be included in NIDCAP strengthen with a parental support on nursing care named PARENTALIM. The group of preterm newborns retrospectively assigned in the study received orofacial stimulations in a standardized protocol way (SOFS) Researchers will compare prospective and retrospective groups to see if the prospective group achieve autonomous oral feeding, despite individual neonatal cumulated risks, significantly earlier than retrospective group.
- Conditions
- Preventive Care
- Being tested
- NIDCAPARENTALIM, SOFS
- Keywords
- preterm newborns, individualized developmental care, parental suppport for nursing, orofacial stimulations, oral feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIDCAPARENTALIMOther
PARENTALIM practice that strengthens the NIDCAP. It is proposed in a routine way in the NICU since 2019. PARENTALIM supports and monitors parental implication in nursing care. It is led by a speach language therapist specialized in early feeding development who proposes 5 individualized interviews and uses an educational booklet on eating development care with a lot of illustrations and few words.
SOFSBehavioural
SOFS is a behavioral practice of orofacial stimulations. Il has been mainly carried out by nurses or a speach language therapist specialized in early feeding development. SOFS has been applied through routine protocol in the NICU until 2018.
| Study group | Role | What they receive |
|---|---|---|
| Prospective NIDCAPARENTALIM | A group of prospectively assigned preterm newborns that will be included in NIDCAP strengthened with a practice focalized on feeding, named PARENTALIM. Receives: Other: NIDCAPARENTALIM | |
| Retrospective SOFS | A group of retrospectively assigned preterm newborns that had standardized orofacial stimulations named SOFS. Receives: Behavioral: SOFS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The precocity of autonomous oral feeding achievement taking into account the index of cumulated neonatal risks
The corrected age in ammenorhea weeks at which preterm newborn achieve autonomous oral feeding will be divided by the index of cumulated neonatal risks scored from the updated risk inventory initially proposed by Sheiner and Sexton in 1991
Measured: 5 years
Secondary outcomes (1)
The duration of oral feeding transition
The duration from the moment when preterm newborn takes 5 ml per kg per day and until the moment when autonomous oral feeding is achieved.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start2 Feb 2019
- Primary completion11 Feb 2019
- Study completion15 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preventive CareStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Other
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CHRISTEL BLAISON, Principal investigator, Speach language Therapist at University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184386
- Sponsor's protocol ID
- 20-161
- Acronym
- PARENTALIM
- Status last verified
- Dec 2023
- First submitted
- 14 Dec 2023
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Parental Feeding Support to Strengthen NIDCAP and Favor Eating Development in Preterm Newborns as Compared With a Retrospective Orofacial Stimulation Standardized and Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT06184386
- Acronym / sponsor ID
- PARENTALIM / 20-161
- Conditions
- Preventive Care
- Keywords
- preterm newborns, individualized developmental care, parental suppport for nursing, orofacial stimulations, oral feeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 2 Feb 2019 (actual)
- Primary completion
- 11 Feb 2019 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 28 Dec 2023 (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.
Preventing oral feeding delays in preterm newborns remains a stake for NICU nowadays. Indeed, it lengthens hospitalization duration, distorts parent-newborns relationships, and increases the risks of adverse nursing outcomes. Does a routine individualized developmental preventive feeding care implying parents favors earlier autonomous oral feeding achievement in preterm newborns as compared with a standardized routine program of orofacial stimulations, despite neonatal risks that every preterm newborn cumulates during hospitalization stay ?
Detailed description
The goal of this observational study is to compare the efficiency of two routine preventive feeding care in preterm newborns, taking into account neonatal cumulated risks for each preterm newborn participant. The main question it aims to answer is: Does a prospective individualized routine developmental preventive feeding care leads to earlier oral feeding achievement in preterm newborns despite individual risks, as compared with a retrospective standardized routine program. The group of preterm newborns prospectively assigned in the study will be included in NIDCAP strengthen with a parental support on nursing care named PARENTALIM. The group of preterm newborns retrospectively assigned in the study received orofacial stimulations in a standardized protocol way (SOFS) Researchers will compare prospective and retrospective groups to see if the prospective group achieve autonomous oral feeding, despite individual neonatal cumulated risks, significantly earlier than retrospective group.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective NIDCAPARENTALIM | – | Other: NIDCAPARENTALIMA group of prospectively assigned preterm newborns that will be included in NIDCAP strengthened with a practice focalized on feeding, named PARENTALIM. |
| Retrospective SOFS | – | Behavioral: SOFSA group of retrospectively assigned preterm newborns that had standardized orofacial stimulations named SOFS. |
Who may qualify
- Ages
- 3 days to 10 weeks
- Sex
- All
- Age groups
- Child
- Study population
- Preterm newborns born before 34 weeks of amenorrhea with variable but moderated neonatal risks and their parents.
Key inclusion criteria (3 listed)
- Parents of preterm newborns born before 34 weeks of amenorrhea
- Parents who agree participating in the study after signing an informed consent.
- Minimal delay of 72 hours and maximal delay of 15 days after birth to inform parents and wait their consent.
Key exclusion criteria (3 listed)
- Parents of preterm newborns born after 35 weeks of amenorrhea
- Parents who disagree participating in the study, even after signing the informed consent.
- Parents of preterm newborns born with cerebral, maxillo-facial, digestive, cardiac, genetic or syndromic abnormalities.
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 |
|---|---|---|
| NIDCAPARENTALIMPARENTALIM practice that strengthens the NIDCAP. It is proposed in a routine way in the NICU since 2019. PARENTALIM supports and monitors parental implication in nursing care. It is led by a speach language therapist specialized in early feeding development who proposes 5 individualized interviews and uses an educational booklet on eating development care with a lot of illustrations and few words. | Other | Prospective NIDCAPARENTALIM |
| SOFSSOFS is a behavioral practice of orofacial stimulations. Il has been mainly carried out by nurses or a speach language therapist specialized in early feeding development. SOFS has been applied through routine protocol in the NICU until 2018. | Behavioural | Retrospective SOFS |
Primary outcome
The precocity of autonomous oral feeding achievement taking into account the index of cumulated neonatal risks
Time frame: 5 years
The corrected age in ammenorhea weeks at which preterm newborn achieve autonomous oral feeding will be divided by the index of cumulated neonatal risks scored from the updated risk inventory initially proposed by Sheiner and Sexton in 1991
1 secondary outcome
The duration of oral feeding transition
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Preventive Care
Active, not recruiting
Working Towards Empowered Community-driven Approaches to Increase Vaccination and Preventive Care Engagement
COVID-19
Recruiting
Lifewise Preventive Video Education in Primary Care
Prevention Harmful Effects, Health Maintenance
RecruitingPhase 2
A Clinical Trial of Extended (High) Treatment Dose Antibiotics in Combination With Methenamine Hippurate Compared to the Standard of Care (Either Prophylactic (Low) Dose Antibiotic Treatment or Methenamine Hippurate) in Females With Chronic Urinary Tract Infection
Chronic Urinary Tract Infection
Active, not recruiting
PREWELL Digital Well-being Promotion Intervention With the BitHabit App
General Mental Health and Well-Being, Mental Disorders
Recruiting
Screen Smart: Using Digital Health to Improve HIV Screening and Prevention
HIV Infections
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. This study is not recruiting at the moment.
CHRISTEL BLAISON principal investigator
Speach language Therapist at University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preventive Care, run by University Hospital, Caen at 1 site in France.
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: finished, as of the sponsor's last update on 28 Dec 2023. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The precocity of autonomous oral feeding achievement taking into account the index of cumulated neonatal risks (time frame: 5 years). 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 28 Dec 2023.