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Completed

NCT Number: NCT06303973

Effect of Oral Enteral Nutrition in Pierre Robin Syndrome

This was a randomized controlled study. The infants enrolled were randomly divided into the IOE group (with Intermittent Oro-Esophageal Tube Feeding, n=25) and the PNG group (with Nasogastric Tube Feeding, n=23), all receiving systemic therapy. Before and after 4-week treatment, pulmonary infection, swallowing function, nutritional status and body weight between the two group were compared.

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Key information

Conditions

Pierre Robin Syndrome Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Jaw Abnormalities Jaw Diseases Maxillofacial Abnormalities Musculoskeletal Abnormalities Musculoskeletal Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

1 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Renai Hospital

Yilan, Taiwan

About this study

Pierre Robin Syndrome (PRS) can cause dysphagia. In China, persistent nasogastric tube feeding (PNG) is the mainstream choice as nutrition support in the dysphagic infants with PRS. However, PNG is associated with various complications, necessitating the exploration for a safer and more effective nutritional support approach. Therefore, this study aims to observe the clinical effect of intermittent oro-esophageal tube feeding (IOE) compared to PNG in the dysphagic infants with PRS who received systemic therapy.

This was a randomized controlled study. The infants enrolled were randomly divided into the IOE group (with IOE, n=25) and the PNG group (with PNG, n=23), all receiving systemic therapy. Before and after 4-week treatment, pulmonary infection, swallowing function, nutritional status and body weight between the two group were compared.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • meeting the diagnostic criteria for Pierre Robin sequence based on CT and X-ray examinations, combined with clinical manifestations and physical signs.
  • with spontaneous vaginal birth, aged 1 to 12 months.
  • with dysphagia screened by the water drinking test and further confirmed by the assessment of Dysphagia Disorders Survey (DDS), Dysphagia Severity Scale (DSS), or Schedule for Oral Motor Assessment (SOMA)
  • before the treatment, the tube feeding was required and feasible after evaluation.
  • stable vital signs.
  • with nasogastric tubes placed before the treatment.
  • sufficient human milk could be provided by the mothers of the patients (with the help of a manual suction device).

Exclusion criteria

  • abnormalities in brain development or other neurological lesions.
  • dysphagia caused by other diseases.
  • other congenital malformations, such as Down syndrome, cleft lip, and palate, etc.
  • severe systemic disease (such as severe infection, severe hepatic and renal dysfunction).
  • participants who need to receive other therapy which would potentially affect the result of this study.

Treatment and study plan

IOE

Device

The specific procedure was as follows: the infant was placed in a semi-recumbent or sitting position with the head fixed. Before each feeding, the infant's oral and nasal secretions were to be cleared. An intermittent oro-esophageal tube (Appendix) was appropriately lubricated with water on the head part. The professional medical staff held the tube and slowly inserted it through one side of the mouth into the upper part of the esophagus. The depth of insertion depended on the patient's age and height. After each feeding, the tube was immediately removed, and the patient was held upright for at least 30 minutes in case of reflux.

PNG

Device

In PNG group, disposable gastric tubes were used for feeding to provide nutritional support. Each feeding was administered by a nurse using the infant's mother's breast milk through the tube. The amount of each feeding varied from 20 to 100 ml depending on the age of the infant, with feedings given every 2 to 3 hours, approximately 10 times per day. The duration of each feeding procedure ranged from 10 to 20 minutes. The total daily intake ranged from 200 to 1000 ml. Each tube was kept indwelling for 5 to 7 days. When the tube needed to be replaced, it was removed after the last feeding of a day and a new tube was to be inserted through the other nostril on the following morning to continue the nutritional support.

Primary outcomes

  1. Number of patients diagnosed as the pulmonary infection "Positive".

    Time frame: Day 1 and Day 28

    Once the symptoms of respiratory tract infection such as fever, cough, sputum, dyspnea, and respiratory distress were observed, the medical staffs would conduct the future exam. With the presence of rales on auscultation of both lungs, examination by CT, the routine blood test, and blood culture, the patients would be diagnosed as the pulmonary infection "Positive".

Secondary outcomes

  1. Nutritional status-total protein

    Time frame: Day 1 and Day 28

    The relevant indicators include total protein (TP, g/L) from the blood test within 24h after admission and the last day of treatment, generally, with empty-stomach infants and in the morning.

  2. Nutritional status-hemoglobin

    Time frame: Day 1 and Day 28

    The relevant indicators include hemoglobin (Hb, g/L)from the blood test within 24h after admission and the last day of treatment, generally, with empty-stomach infants and in the morning.

  3. Nutritional status-albumin

    Time frame: Day 1 and Day 28

    The relevant indicators include albumin (ALB, g/L)from the blood test within 24h after admission and the last day of treatment, generally, with empty-stomach infants and in the morning.

  4. Nutritional status-prealbumin

    Time frame: Day 1 and Day 28

    The relevant indicators include prealbumin (PA, mg/L) from the blood test within 24h after admission and the last day of treatment, generally, with empty-stomach infants and in the morning.

  5. Body weight

    Time frame: Day 1 and Day 28

    Body weight measurement of the infants was conducted by the same nurse according to the relevant standards.

  6. Swallowing function

    Time frame: Day 1 and Day 28

    The water drinking test (WDT) was used to assess the swallowing function due to the low feasibility of using swallowing imaging or flexible laryngoscopy in the infants with PRS and that these patients were unable to communicate and cooperate to complete the subjective components of most questionnaires. The patients were required to sit and drink 30 mL of warm water. Based on the completion of water intake and the occurrence of coughing, the results were divided into levels 1 to 6, with higher levels indicating a more severe degree of dysphagia.

Sponsors and collaborators

Lead sponsor

Muhammad

Other

Registry information

Official study title

Effect of Oral Versus Nasal Enteral Nutrition in Pierre Robin Syndrome: A Randomized Controlled Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 12, 2024
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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