CompletedNot Applicable

Cot-side Suckometry and Oral Stimulation in Very Preterm Infants: A Pilot Study

France17 participantsStarted 2012-05-30

Plain-language summary

Very preterm infants - born before 32 weeks' gestational age - commonly experience delayed transition to oral feeding due to immature suck-swallow-breathe coordination. This prospective pilot study have two aims: (1) to assess the feasibility of cot-side non-nutritive sucking assessment (suckometry) from the first postnatal days in very preterm infants; and (2) to characterise early sucking performances before and after routine implementation of a structured oral stimulation protocol. Very preterm infants - born before 33 weeks gestational age - enrolled in a single-centre level III neonatal unit. Sucking performance measured weekly using a novel bedside suckometer from the first postnatal week until full oral feeding autonomy. Clinical outcomes and sucking parameters compared between non-stimulated (NOSTIM) and stimulated (STIM) groups.

Who can participate

Age range

6 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Gestational age at birth: 27 to 32 weeks
. Admitted to the level III neonatal intensive care unit, Hôpital de la Croix-Rousse, Lyon

Exclusion criteria

. Ongoing sedation or analgesia
. Severe neurological injury: intraventricular haemorrhage grade ≥2 or periventricular leukomalacia
. Major congenital anomalies or chromosomal abnormalities
. Necrotising enterocolitis

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility of bedside suckometry (successful recordings rate)

Timeframe: From first postnatal week until full oral feeding autonomy, up to approximately 7 weeks

Trial details

NCT IDNCT07632066

SponsorHôpital de la Croix-Rousse

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2013-05-01

View on ClinicalTrials.gov More Prematurity; Extreme trials