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A Randomized Controlled Clinical Trial of Pediatric Massage Therapist-Coordinated Interventions to Improve Feeding Difficulties in Low Birth Weight Infants

A Randomized Controlled Clinical Trial of Pediatric Massage Therapist-Coordinated Interventions to Improve Feeding Difficulties in Low Birth Weight Infants

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001317
Enrollment
Unknown
Registered
2026-05-26
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant feeding difficulties

Interventions

Experimental group:Routine Care+Pediatric Massage Therapist-Coordinated Interventions
Control group:Routine Care+Home Touch Therapy Plan

Sponsors

Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: 1. Birth weight: birth weight < 2500 grams. 2. Gestational age: gestational age at birth = 28 weeks and < 37 weeks. 3. Health status: vital signs are stable, discharged from the NICU, able to feed orally (without the need for nasogastric or intravenous nutrition). 4. Age: corrected age at discharge, with chronological age not exceeding 40 weeks of corrected gestational age. 5. Guardian: the primary guardian (father or mother) is willing to sign a written informed consent form, and commits to complying with the study protocol and completing all follow-ups.

Exclusion criteria

Exclusion criteria: 1. Major congenital diseases: such as known severe congenital heart disease that seriously affects feeding or growth (e.g., complex congenital heart disease requiring medication or surgical intervention), severe cleft lip and palate, congenital digestive tract malformations, known chromosomal disorders or inherited metabolic diseases. 2. Severe nervous system injury: such as Grade III or higher intraventricular hemorrhage (IVH) or periventricular leukomalacia (PVL) confirmed by cranial ultrasound or MRI, or a history of seizures. 3. Severe complications: patients with severe bronchopulmonary dysplasia (BPD) requiring long-term oxygen therapy, sequelae stage of necrotizing enterocolitis (NEC), etc. 4. Skin condition: presence of systemic or localized skin diseases at the massage site, making massage unsuitable. 5. Other factors: currently participating in other clinical studies that may affect growth and feeding.

Design outcomes

Primary

MeasureTime frame
Z scores of age/weight;Z scores of age/head ;Z scores of age/length;Z scores of length/weight;

Secondary

MeasureTime frame
Feeding tolerance (incidence of vomiting / bloating);Time to reach full enteral feeding;Feeding efficiency (milk volume, feeding time);

Countries

China

Contacts

Public ContactKOU Chen

Beijing Obstetrics and Gynecology Hospital, Capital Medical University

kcviva@ccmu.edu.cn13810120019

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 11, 2026