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Official title Effects of Staged Adapted Inclusions in Infant Cereals on Oral-motors Patterns of 6-24 Month-old Children
ClinicalTrials.gov ID: NCT07318506
What this study is testing
- What it's testing
- The purpose of this study is to define the effects of different inclusions in infant cereals on the adaptation of oral motor behavior and skills displayed at a given age.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 6. Healthy volunteers may be eligible.
You may be able to join if
- Children between 6 months (182 days) to 24 months (730 days) of age (from enrollment to last visit): 1.1. [182-242]-days of age from V1 to last visit...
- Singleton, full-term infants (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg.
- Healthy children based on medical history as reported by parent(s) / LAR(s).
- Sit upright with or without support (such as, sitting with back against a chair or while being held) as reported by parent(s) / LAR(s)
- Keep head steady when in a supported position
You likely can't join if
- 1\. Infant's parents or LARs have not reached legal age of majority (18 years) 2. Children with history of oral/facial malformations or surgery (i.e...
- 3\. Children with any chronic illness, congenital malformations (e.g., esophageal or intestinal atresia), surgical sequela (e.g., short bowel...
- 4\. Children with feeding or swallowing difficulties/disorders, history of choking, or at high risk of choking.
- 5\. Child or sibling(s) who has known or suspected food allergy or intolerance, such as cows' milk protein allergy, celiac disease, lactose...
- 6\. Children with undernutrition as determined by age-group weight threshold (based on parental reports): weight at [6-8[month \< 6 kg; weight at...
- 7\. Child is currently participating in or has participated in another intervention clinical study that impacts study outcomes within 4 weeks prior...
See the full eligibility criteria
- Children between 6 months (182 days) to 24 months (730 days) of age (from enrollment to last visit): 1.1. [182-242]-days of age from V1 to last visit for the 6-8-month-old age group 1.2. [243-364]-days of age from V1 to...
- Singleton, full-term infants (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg.
- Healthy children based on medical history as reported by parent(s) / LAR(s).
- Sit upright with or without support (such as, sitting with back against a chair or while being held) as reported by parent(s) / LAR(s)
- Keep head steady when in a supported position
- Have already started complementary feeding as recommended by their health care professional (have started solid food beyond breastmilk or infant formula)
- Written informed consent is obtained from at least one parent(s) / LAR(s).
- Parent(s) / LAR(s) must be able to provide evidence of parental authority and identity.
- Parent(s) / LAR(s) must understand the informed consent and other study documents.
- Parent(s) / LAR(s) are willing and able to fulfill the requirements of the study protocol within the study timeframe.
- 1\. Infant's parents or LARs have not reached legal age of majority (18 years) 2. Children with history of oral/facial malformations or surgery (i.e. cleft lip, cleft palate, tongue-tie/ankyloglossia), or history of...
- 3\. Children with any chronic illness, congenital malformations (e.g., esophageal or intestinal atresia), surgical sequela (e.g., short bowel syndrome), gastroesophageal reflux disease, behavioral disorders...
- 4\. Children with feeding or swallowing difficulties/disorders, history of choking, or at high risk of choking.
- 5\. Child or sibling(s) who has known or suspected food allergy or intolerance, such as cows' milk protein allergy, celiac disease, lactose intolerance, soy allergy, fish allergy, or any other suspected or confirmed...
- 6\. Children with undernutrition as determined by age-group weight threshold (based on parental reports): weight at [6-8[month \< 6 kg; weight at [8-12[months: \< 6.5 kg; weight at [12-18[months: \< 7.5 kg; weight at...
- 7\. Child is currently participating in or has participated in another intervention clinical study that impacts study outcomes within 4 weeks prior to enrolment or has participated in another age group of this study.
- 8\. Family or hierarchical relationships with the research team members.
The study team makes the final eligibility decision.
Where it's taking place
- Barcelona, Spain
- Valencia, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months to 6 months. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barcelona, Spain; Valencia, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.